European Journal of Heart Failure (2013) 15, 1304–1310

doi:10.1093/eurjhf/hft097

Salt and fluid restriction is effective in patients

with chronic heart failure
Henriette Philipson*, Inger Ekman, Heléne B. Forslund, Karl Swedberg,
and Maria Schaufelberger
University of Göteborg, Sahlgrenska Academy, Göteborg, Sweden

Received 17 December 2012; revised 23 May 2013; accepted 24 May 2013; online publish-ahead-of-print 19 June 2013

Aims European and American guidelines have recommended salt and fluid restriction for patients with chronic heart failure
(CHF) despite scarce scientific evidence. Therefore, we investigated the effects of salt and fluid restriction in patients
with CHF.
.....................................................................................................................................................................................
Methods Ninety-seven stable patients in NYHA class II– IV, on optimal medication, with previous signs of fluid retention, treated
and results with either .40 mg (NYHA III– IV) or .80 mg (NYHA II–IV) of furosemide daily were randomized to either individua-
lized salt and fluid restriction or information given by the nurse-led heart failure clinics, e.g. be aware not to drink too much
and use salt with caution, and followed for 12 weeks. Fluid was restricted to 1.5 L and salt to 5 g daily, and individualized
dietary advice and support was given. The 24 h dietary recall procedure, urine collection on three consecutive days, and
para-aminobenzoic acid 80 mg t.i.d. was used to assess adherence to diet and completeness of urine collection. The
primary endpoint was a composite variable consisting of NYHA class, hospitalization, weight, peripheral oedema,
quality of life (QoL), thirst, and diuretics.
.....................................................................................................................................................................................
Results After 12 weeks, significantly more patients in the intervention than in the control group improved on the composite end-
point (51% vs. 16%; P , 0.001), mostly owing to improved NYHA class and leg oedema. No negative effects were seen on
thirst, appetite, or QoL.
.....................................................................................................................................................................................
Conclusion Individualized salt and fluid restriction can improve signs and symptoms of CHF with no negative effects on thirst, appetite,
or QoL in patients with moderate to severe CHF and previous signs of fluid retention.
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Keywords Heart failure † Fluid restriction † Salt restriction † Quality of life

mildly symptomatic patients.4 Another study found that patients re-

Introduction
European and American guidelines for the non-pharmacological
treatment of patients with chronic heart failure (CHF) recommend
dietary salt and fluid restriction, especially in moderately to severely
symptomatic patients;1,2 however, this recommendation lacks con-
vincing scientific documentation and evidence. In the 2012 guidelines
from the European Society of Cardiology (ESC), the recommenda-
tions have been changed to ‘avoid excessive fluid intake’ and ‘weight-
based fluid restriction may cause less thirst’, and salt restriction is
listed in ‘Gaps in evidence’.3 Salt and fluid restriction has been
shown to decrease urinary sodium excretion and extracellular
water; however, the study sample comprised asymptomatic or
ceiving high doses of furosemide, fluid intake restricted to 1 L day, and
a sodium restriction of 80 mmol/day had a worse outcome than
those on 120 mmol/day.5 In a meta-analysis of six randomized trials
of low vs. normal sodium diet including 2747 patients, a low
sodium diet increased all-cause mortality.6 However, all studies in
the meta-analysis came from the same research group who had
used a very similar approach in all studies (high doses of diuretics
and 1 L fluid daily in addition to salt reduction). In stable patients
with moderate CHF, favourable effects on thirst and adherence to
a liberal fluid restriction based on body weight have been reported.4
Salt and fluid restrictions interfere with the patients’ eating habits and
quality of life (QoL), which in turn may impact negatively on

* Corresponding author. Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy, University of Gothenburg, Box 459, SE 405 30 Göteborg, Sweden.
Tel: +46 317863715, Fax: +46 317863101, Email: henriette.philipson@nutrition.gu.se
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2013. For permissions please email: journals.permissions@oup.com.
Salt and fluid restriction in patients with CHF
adherence. Patients also relate their thirst to the loss of body
water caused by diuretics7 (even if tolvaptan is the only drug reported
to increase thirst8). Eating habits may also change with age, with
a higher use of ready meals. In addition, salt restrictions may result
in loss of appetite as food loses its appeal and taste, and fluid restric-
tions may cause an increase in thirst.9 – 11 Consequently, there is a
need to know if salt and fluid restriction improves functional ability
and reduces hospitalizations without concomitant negative impacts
on QoL.
In a previous pilot study, we found that patients with moderate to
severe CHF were able to reduce their sodium and fluid intake
without any negative effects on thirst, appetite, and QoL.12 There-
fore, we wanted to evaluate the effect of salt and fluid restriction
on a composite endpoint, consisting of NYHA class, hospitalization,
body weight, peripheral oedema, QoL, thirst, and diuretics, in a
powered study to obtain solid evidence for recommendations for
its use in CHF patients.
Methods
Study design
In a 12-week prospective, randomized, multicentre intervention trial,
patients were allocated to either a individualized salt and fluid restriction
(intervention group) or information given by the nurse-led heart failure
clinics, e.g. be aware not to drink too much and use salt with caution
(control group).1 The patients were stratified according to age (≤70
years) and dose of diuretics (≤80 mg of furosemide or equipotent
doses of other diuretics). A separate randomization list was produced
for each stratifying variable using block randomization in groups of
four. The study was approved by the Regional Ethical Review Board of
the University of Gothenburg.
Patients with a history of CHF, in NYHA class II–IV, from the Sahlgrenska
University Hospital, Gothenburg and Södra Älvsborg, Hospital Borås were
prospectively enrolled. Inclusion criteria were: stable condition; documen-
ted LV dysfunction (EF ≤40%, or .40% and a history of hospitalization for
heart failure); a history of signs of fluid retention (on chest X-ray or periph-
eral oedema); on maximum tolerated doses of ACE inhibitors/ARBs and
beta-blockers with no change in medication for at least 2 weeks prior to
enrolment; and ≥ 80 mg of furosemide or equipotent doses of others
diuretics for patients in NYHA II or ≥ 40 mg of furosemide for patients
in NYHA III–IV. Exclusion criteria were: concomitant liver or renal dis-
order (serum creatinine .250 mmol/L) causing fluid retention; present
fluid retention requiring adjustment of diuretics; other diseases limiting
the patients’ physical capacity; and lack of ability to follow instructions,
e.g. patients with dementia and language problems. The study physician
determined the lack of ability to follow instructions.
Outcome on the primary composite endpoint after 12 weeks was
defined as follows.
(i) Deterioration. Patients were considered to have deteriorated if they
met any of the following criteria: (a) deterioration at least one
NYHA class; (b) hospitalization for heart failure; (c) weight gain ≥
2 kg; (d) increased leg oedema ( ≥ 1 point on a 4-point scale); (e)
increased thirst ( ≥ 2 points on a 10-point scale); or (f) reduced
QoL ( ≥ 2 points on a 6-point scale). Hence, even if a patient improved
in all other criteria, patient was classified as ‘deterioration’ if only one
of the criteria had deteriorated.
(ii) Improvement. Patients were considered to have improved if none of
the above criteria were met and if they met at least one of the follow-
ing criteria: (a) improved at least one NYHA class; (b) weight loss ≥
1305
2 kg; (c) decreased leg oedema ( ≥ 1 point on a 4-point scale); (d)
improved QoL ( ≥ 2 points on a 6-point scale); or (e) decreased
dose of diuretics ( ≥ 40 mg of furosemide).
(iii) Unchanged. Patients were considered unchanged if they did not meet
any of the criteria in either (i) or (ii) above.
The physicians taking part in the study (n ¼ 8) all discussed very carefully
at the beginning of the study how to assess the different variables so that a
consensus was reached. At baseline, the patient’s medical history was
recorded and a physical examination was performed. Blood samples
for analysis of serum sodium, serum potassium, serum creatinine,
serum NT-proBNP. and serum haemoglobin were collected from each
patient. Height and weight were measured. Thereafter the patients
were instructed to collect a 24 h urine sample on three consecutive
days. To verify the completeness of the urine collection, the patients
were given para-aminobenzoic acid (PABA; 80 mg t.i.d.) on the first day
of urine collection.13,14 Urine collections containing 75 – 100% of the
PABA consumed were classified as complete. Collections containing
50 – 75% of the PABA were considered incomplete and in such cases
urine sodium was estimated by means of linear regression analysis.15
Urinary collections with , 50% of the PABA in any of the samples
were excluded from the analysis.14,15 After urine collection, the patients
completed a validated QoL instrument16 and rated fatigue, thirst, and
appetite on 10 cm visual analogue scales (VAS).17 Diet was registered
using the semi-quantitative Food Frequency Questionnaire (FFQ).18
Meal pattern information was gathered in an food anamnesis and the
24 h dietary recall procedure was used as the instrument for dietary
counselling.19
Subsequently, patients were randomized into either the intervention
group or the control group. The physicians were blinded to the random-
ization. The patients, family members, study nurses, and dieticians were
asked not to reveal the patient’s randomization status to the physicians.
Baseline investigations were repeated after 12 weeks.
Intervention group
The dietary recommendations were individualized, taking into consider-
ation the patient’s cultural, economic, and social habits, and were based
on the results of the 24 h dietary recall and the semi-quantitative
FFQ.18 A registered dietician (RD) or a specially trained registered
nurse (RN), coached by a dietician and in continuous dialogue with the
dietician about nutritional problems, discussed and gave advice to the
patients about how to reduce sodium intake to 2 – 3 g/day (correspond-
ing to 5 g of salt per day) and to limit fluid intake to a maximum of 1.5 L/
day. Patients reported fluid intake as the volume of their own glasses and
cups of fluid consumed and there were no restrictions on water content
in foods, except for dinner soups and liquid desserts. The importance of
maintaining a constant energy level was emphasized. For detailed infor-
mation, see the pilot study.12
Follow-ups were performed at a visit with the study nurse after 4
weeks and by telephone, without prior announcement, by the RD or
the specially trained RN every 2 – 3 weeks. A 24 h dietary recall was
used at each contact to follow the patients’ adherence to the dietary
advice20 and as a basis for giving additional guidance on how to limit
the salt and fluid intake. Patients were encouraged to ask questions
about their food choices, cooking, and how to cope with fluid and salt
restrictions.
Control group
The RD or the specially trained RN provided the patients with informa-
tion given by the nurse-led heart failure clinics, e.g. ‘be aware not to drink
too much and use salt with caution’.
1306 H. Philipson et al.

One-year follow-up
Patients were contacted by telephone after 10–12 months by a dietician
without prior announcement. A 24 h dietary recall interview was per-
formed and patients completed a questionnaire about adherence to
the salt and fluid dietary advice given during the study period.
two-tailed, independent sample t-test for continuous, normally distribu-
ted data, and Mann – Whitney U-test for skewed, continuous variables.
Missing data were not imputed.
Pearson’s x2 was used for categorical variables. A two-tailed P , 0.05
was considered significant.

Statistical analysis
To show a 20% difference in favour of the intervention with 80% power at
the 5% significance level, a power calculation generated a need for 97
patients in each group. All analyses were performed with the Predictive
Analytics SoftWare (PASW version 18 for Windows, Chicago, IL,
USA). Data are presented as mean + standard deviation (SD) for con-
tinuous variables and were analysed according to intention to treat
(ITT). All patients who were unchanged in terms of the composite end-
point were considered worse, since the intervention was aimed to show
improvement. Comparisons between the groups were made using the
Results
Ninety-seven patients (60 males and 37 females) with a mean age of
75 (+8) years agreed to participate in the study. Baseline information
is shown in Table 1. Forty-nine patients were randomized to the inter-
vention group and 48 patients to the control group. Two patients
withdrew consent after randomization (one in each group), three
dropped out due to other disabling diseases (two in the intervention
and one in the control group), and two patients died (one in each

Table 1 Baseline demographics and clinical characteristics of the study population

Intervention group, n 5 49 Control group, n 5 48

...............................................................................................................................................................................
Gender (male/female), n 32/17 26/22
Age, years 74 (8.6) 76 (7.5)
Height, m 1.73 (0.09) 1.69 (0.1)
Females 1.64 (0.09) 1.62 (0.08)
Males 1.76 (0.07) 1.75 (0.07)
Weight, kg 84.9 (16.1) 82.8 (16.2)
Females 79 (20.6) 78.1 (15.2)
Males 87.5 (22.1) 86.9 (16.3)
Body mass index, kg/m2 29 (7.0) 29 (4.8)
Females 30 (5.8) 30 (7.8)
Males 28 (6.8) 28 (4.5)
Body mass index, ≤22 kg/m2, n 4 5
NYHA class, II/III/IV, n 10/39/0 13/35/0
EF, % 34 (11) 37 (15)
EF ≤45%, n 38 36
Heart rate, b.p.m. 68 (10) 69 (7)
Neck vein distension, yes/no 25/24 32/16
Leg oedema, 0– 3 17/13/17/1 22/14/12
Diastolic blood pressure, mmHg 73 (12) 73 (10)
Pulmonary rales, 0– 4 0.4 (0.5) 0.3 (0.5)
Enlarged liver, yes/no 42/7 40/8
NT-proBNP, ng/L, median (range) 1455 (136–14 264) 1265 (33–11 463)
Serum sodium, mmol/L 139 (3) 139 (3)
Serum potassium, mmol/L 4.3 (0.5) 4.3 (0.4)
Haemoglobin, g/L 136 (12) 136 (13)
Urinary sodium, mmol/L 152 (70) n ¼ 33 140 (51) n ¼ 36
Urinary potassium, mmol/L 57 (18) n ¼ 33 59 (17) n ¼ 36
Furosemide, mg 90 (68) 93 (68)
Spironolactone, n 14 19
Beta-blockers, n 37 35
ACE inhibitor/ARB, n 35 33
ACE-I and ARB, n 4 0
Digoxin, n 12 12
Long-acting nitrates, n 10 11

All data are th emean (SD) unless otherwise indicated.

Pulmonary rales were graded 0–4 where 0 is none and 4 is pulmonary oedema.
Salt and fluid restriction in patients with CHF
Figure 1 Numbers of improved or deteriorated patients in the
intervention and control groups. P , 0.001 is for the number for
patients with the improved vs. the deteriorated composite endpoint.
group). Thus, 45 patients in each group completed the study. In 67
cases it was the same physician examining the patients at baseline
and follow-up and in the rest it was two different physicians who
had worked together for 5– 25 years. One physician made 72% of
the evaluations.
Improvement in the primary composite endpoint was seen in 51%
of the patients in the intervention group and in 16% in the control
group, P , 0.001 (Figure 1), mostly due to an improved NYHA
class and reduced oedema (Table 2). Changes in the specific compo-
nents of the composite endpoint are shown in Figure 2.
Twelve patients in the intervention group and nine patients in the
control group were excluded from the urine analysis, owing to PABA
,50% in all of the urine samples. There were significant reductions in
urine volumes and urine sodium in the intervention group from base-
line to follow-up compared with the control group (Table 2). Neither
weight, thirst, nor QoL were affected by the salt and fluid restrictions.
Dose of diuretics was reduced in five patients in the intervention
group and three in the control group. Spironolactone was decreased
in two patients in the intervention group and in one in the control
group, and the dose was increased in one patient in the control
group. In the intervention group, the dose of ACE inhibitor/ARB
was increased by the general practitioner (GP) in one patient for
unclear reasons 4 weeks after study start, and after 6 weeks in the
study another patient was told to halve his dose of ARB due to a
long period of fever. No dose changes were seen in the control
group.One patient in the intervention group and two in the control
group were hospitalized.
A total of 38 patients (21 patients in the intervention group and 17
controls) were contacted by telephone 10–12 months after their last
visit. Three in the intervention group and four in the control group
were either too tired or not interested in taking part in the interview.
All participants in the intervention group considered that they had
modified their diet during the study period, and 11 of 21 said that
they maintained this dietary pattern. Four patients no longer prepared
their own meals. In the control group, 4 of 13 felt that they had made
major dietary changes after the end of the 12-week study period.
Discussion
In this study, salt and fluid restrictions were associated with a signifi-
cant improvement in a composite endpoint, comprising NYHA class,
hospitalization for heart failure, weight, leg oedema, QoL, thirst, and
1307
lowered dose of diuretics, in patients with CHF. We believe the
effects of the intervention were obtained because concerted
efforts were made to meet the nutritional needs of the individual
and to promote a good nutritional status with an individualized
dietary plan.
Salt and fluid restriction has long been recommended for patients
with CHF in national and international guidelines,1,2 although the sci-
entific evidence has to date been weak. In the 2012 ESC guidelines,
the salt and fluid restrictions have been modified to ‘avoid excessive
fluid intake’, ‘weight-based fluid restriction may cause less thirst’, and
salt restriction is listed in ‘Gaps in evidence’.3
However, the present study gives support to this recommenda-
tion. The earlier lack of evidence is understandable as salt and fluid
intake is difficult to assess reliably, especially in an outpatient
setting. In addition, it can be hard for this patient group, i.e. elderly,
ailing patients often on diuretics, to follow diet instructions. Hence,
we conducted a pilot study12 in advance of this study to verify the
feasibility of the study procedure. The present study adds to our
knowledge about the efficacy of salt and fluid restriction.
Fluid restriction
Fluid restriction of 1.5 L daily has long been recommended for
patients with CHF in guidelines.1 – 3 To our knowledge, there are
only a few randomized trials of fluid restriction in patients with HF.
For example, in a small, in-hospital study comparing a fluid-restricted
diet (1 L/day) with free fluid intake, no differences were found in days
of hospitalization, time to discontinuation of i.v. diuretics, or stabiliza-
tion of urea, creatinine, or potassium. The authors therefore con-
clude that fluid restriction has no clinical benefit for this group of
patients.21 In an outpatient setting, Holst and co-workers compared
two different fluid restriction regimens and found that liberal fluid
intake (30 –35 mL/kg body weight/day) was not significantly better
than a restricted fluid intake (1.5 L/day) with respect to body
weight, signs and symptoms, diuretic use, QoL, or physical capacity.9
However, patients with the more liberal fluid regimen complained
less about thirst.22 In our study, only a few patients complained of
thirst, possibly owing to the fact that we made a point of openly ex-
changing ideas with the patients about how best to spread out fluid
intake over the course of the day.
Salt and fluid restriction
In a study using the same salt and fluid restrictions as ours but with a
more complicated diet, Colin Ramirez and co-workers4 showed that
decreased fluid intake and urinary sodium excretion results in less fre-
quent oedema and fatigue, and improved NYHA class and QoL.4
These results are in accordance with our findings, although their
patients were ‘healthier’ than ours in the sense that nearly 60% of
the patients in that study were NYHA class I already at baseline. In
addition, the patients were relatively small, 64 (+16) kg and 1.52
(+ 0.11) m compared with the averages for persons in Western
countries. Furthermore, the lack of control of real fluid intake and
urinary excretion makes it difficult to evaluate adherence to the
dietary restrictions.
Salt restriction
Guideline recommendations for salt intake in patients with CHF vary
from the vague ‘excessive intake of salt should be avoided’1 to the
 1308

Table 2 Between-group comparisons of change in clinical signs, quality of life, fluid intake, and urinary excretion of sodium from baseline

Intervention group (n 5 45) Control group (n 5 45) P-valuea

................................................................. .................................................................
Baseline (n 5 45) 12 weeks (n 5 45) Baseline (n 5 45) 12 weeks (n 5 45)
.............................................................................................................................................................................................................................................
NYHA I/ II/III/IV, n 0/10/35/0 1/16/28/0 0/12/33/0 0/10/35/0 0.01
Weight, kg 85 (16) 84 (22) 83 (16) 83 (17) NS
BMI, kg/cm2 29 (7.0) 29 (4.8) 29 (5.2) 28 (4) NS
Heart rate, b.p.m. 69 (11) 68 (10) 69 (12) 69 (11) NS
Leg oedema, 0– 3 15/12/17/1 29/12/4/0 21/13/11 24/11/10/0 0.01
Serum potassium, mmol/L 4.2 (0.4) n ¼ 33 4.4 (0.5) n ¼ 33 4.3 (0.4) n ¼ 35 4.3 (0.5) n ¼ 35 NS
Serum sodium, mmol/L 139 (3) 139 (3) 139 (3) 139 (3) NS
Haemoglobin, g/L 136 (11) 136 (13) 136 (13) 133 (16) NS
NT-proBNP, ng/L, median (range) 1455 (136– 14 264) 1640 (33–11 500) 1265 (33– 11 463) 1665 (66– 12 900) 0.13
Serum creatinine, mmol/L 121 (39) 117 (37) 118 (28) 124 (24) 0.03
Urinary sodium, mmol/24 hb 152 (70) n ¼ 33 137 (62) n ¼ 33 140 (51) n ¼ 36 139 (70) n ¼ 36 0.04
Urinary potassium, mmol/24 hb 57 (18) n ¼ 33 62 (22) n ¼ 33 59 (17) n ¼ 36 59 (24) n ¼ 36 NS
Urinary volume, L/24 hb 1.89 (0.9) n ¼ 33 1.54 (0.7) n ¼ 33 1.75 (0.7) n ¼ 36 1.66 (0.8) n ¼ 36 0.04
Furosemide, mg 90 (68) 88 (68) 93 (68) 90 (69) NS
Thirst, VAS 4.2 (1.7) 4.4 (1.9) 4.4 (1.8) 5.2 (2.0) 0.06
Appetite, VAS 7.0 (2.5) 7.2 (2.5) 6.7 (2.4) 6.9 (2.2) NS
Fatigue, VAS 5.5 (1.8) 5.0 (1.9) 5.4 (1.8) 5.7 (2.1) 0.16
Quality of life, 1– 6 4.25 (0.8) 4.25 (1.0) 4.1 (1.2) 4.3 (0.9) 0.11

Data are presented as the mean (SD), unless otherwise indicated. All comparisons were made on an intention-to-treat basis.
Quality of life is the mean of a 7-grade scale (0–6) where 0 is the worst and 6 the best.
Thirst, appetite, and fatigue are expressed as the mean of a 10 cm VAS. Leg oedema is the mean of a 4-point scale (0 –3) where 0 is the best and 3 the worst.
BMI, body mass index; VAS, visual analogue scale.
a
P-values represent the difference in change between the groups.
b
Mean of three consecutive 24 h urine collections.
H. Philipson et al.
Salt and fluid restriction in patients with CHF
Figure 2 Change in the different components of the composite endpoint. Qol, quality of life.
specific ‘patients should be educated to limit their salt intake to a
maximum 2–3 g sodium daily’.23 In line with the latter, a salt restric-
tion of 2 –2.4 g sodium daily has previously been shown to decrease
urinary sodium excretion and improve NYHA class and QoL.4 This
finding was confirmed in our study. On the other hand, another
study showed that patients with furosemide doses of 250–500 mg
t.i.d., a fluid intake of 1 L/day, and a sodium restriction of 80 mmol/
day had a worse outcome than those on 120 mmol/day.5 That
study differs from ours in several ways, the most exceptional differ-
ence being that their patients were on high doses of diuretics and
low fluid intake. Hence, we agree with the authors that their results
must be interpreted with caution.5 In contrast, a recent prospective
study has shown that patients with CHF and a high sodium diet have a
greater risk of acute decompensated heart falure, all-cause hospital-
ization, and mortality.24
One of the challenges in research studies on salt restriction is to
assess adherence to a low salt diet effectively, which was done by
means of urine collection in both Colin Ramirez et al. 4 and the Heart
Failure Society of America study.22 To ensure that the urine collection
is complete, it is essential to use a marker in the urine. In our case, we
selected PABA as the marker for urine collection completeness. The
use of urine PABA concentrations also enables sodium intake to be
estimated when urine collections are incomplete. To our knowledge,
this is the best method available today.13,14
Dietary recommendations
Prochaska et al.25 maintain that lifestyle changes, and especially diet
changes, are difficult to realize in elderly patients.26,27 In this study,
the dietary recall procedure and the modified semi-quantitative
FFQ18 were used to optimize nutrition counselling and to gain a com-
prehensive understanding of the patients’ personal eating habits. The
counselling was tailored to each person and discussed in such a way
that the patients were able to adhere to the new diet without negative
impacts on QoL. To support and maintain the dietary changes, un-
announced telephone interviews were conducted using the 24 h
dietary recall procedure, which also served as input for additional
guidance and dietary instruction.20
1309
Since sodium is unevenly distributed in the everyday diet and is
influenced by our priorities, which, in turn, are influenced by cultural
and culinary traditions, the generalizability of our results has to be
made with some caution. However, we believe that the individualiza-
tion of change of diet, which was done in this study, has to be one
cornerstone of the therapy, and this can be done in all cultural set-
tings, making the results generalizable.
Limitations
First, most of the patients in both groups had already received dietary
instructions in accordance with CHF guidelines prior to inclusion.1,2
Although it is common practice today to give CHF patients such
advice, we were careful to ensure that the control group received
standard dietary instructions. It is conceivable that the observed
effects of salt and fluid restriction would have been greater if the
patients had not received prior dietary advice. Secondly, it is impos-
sible to perform a double blind intervention diet study out of hospital.
To limit this bias, the physicians who examined the patients at base-
line and follow-up were blinded to the randomization. Thirdly, all
patients were on diuretics, which can interfere with the salt and
water balance; however, doses were changed only in a few patients
and we therefore do not consider that this affected our results.
Fourthly, the study had a limited follow-up of 12 weeks. A longer
follow-up would most probably have led to more events and more
power. In addition, at the 1-year telephone follow-up, more than
half of the patients had also maintained the dietary pattern after the
end of the study. The limited power is probably the reason for the dis-
crepancy between the positive findings for NYHA class and oedema,
while the components of QoL, e.g. thirst, were neutral. Seven
patients (7%) dropped out of the study, of which two patients died.
Hence, only five patients were not willing or able to finish the
study. The few drop-outs, which is a strength not a limitation,
shows that the regimen chosen in the intervention was possible to
follow. Fifthly, even for healthy subjects, it is difficult to remember
to sample all urine, and our patients were old and sick, thus it was
even more difficult for them to remember to collect their urine
and also to get the complete amount of urine into the container.
However, even if there are weaknesses with this method, it is to
1310
our knowledge the best one available today in outpatients, especially
as we gave PABA to the patients during one of the 24 h urine sampling
periods, Sixthly, renal function is often decreased in the elderly and
may interfere with PABA excretion. Nevertheless, it is essential to
verify the completeness of the urine collection, and we believe that
assessing PABA recovery is the best and most appropriate method
for this purpose.
Finally, we did not reach the calculated number of patients since
the study became too extended in time. However, even if the study
was underpowered, it reached statistical significance in the pre-
defined composite endpoint. Therefore, we believe the results are
true and add information to earlier knowledge in the field. The
limited power is probably the reason for the discrepancy between
the positive findings for NYHA and oedema, while the components
of QoL, e.g. thirst, were neutral.
Conclusion
Individualized salt and fluid restriction were associated with improve-
ment in a combined endpoint comprising hospitalizations, NYHA
class, QoL, thirst, and clinical parameters of fluid retention in patients
with CHF. This intervention was designed such that it could be easily
implemented in all heart failure clinics.
Funding
The Swedish Heart and Lung Foundation.
Conflict of interest: none declared.
Acknowledgements
We thank associate Professor Bert Andersson, Sahlgrenska Univer-
sity Hospital/Sahlgrenska, Gothenburg, and senior physician Björn
Fredriksson, Södra Älvsborg Hospital, Borås for help in including
patients in the study, and research nurse Sven-Eric Hägelind for
invaluable contributions.
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