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Heart Failure

HF: Medical Nutrition Therapy (2016)


Arcand JL, Brazel S, Joliffe C, et al, Education by a dietitian in patients with heart failure results in improved adherence with a sodium-restricted diet:  A randomized trial. Am Heart J. 2005; 150: 716e1-716e5.

Study Design:
Randomized Controlled Trial
A - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To compare two strategies to prescribe a sodium-restricted diet to patients with stable diuretic-requiring heart failure: Counseling by a resgistered dietitian vs. standard delivery of written educational materials to patients.

Inclusion Criteria:
  • Stable HF
  • Left ventricular ejection fraction (LVEF) under 35%
  • Taking 20mg or more of furosemide daily 
  • Without hospitalization or diuretic dose change in the previous three months
  • Able to read and comprehend a nutrition education package.
Exclusion Criteria:
  • Institutionalized without meal and food choices
  • Nutrition counseling from a dietitian within the past six months
  • Insulin-requiring diabetes
  • Serum creatinine above 185mmol per L
  • Unable to give informed consent.
Description of Study Protocol:


Consecutive patients at an ambulatory heart function clinic at Mount Sinai Hospital in Toronto.


  • Randomization into either dietitian education or usual care
  • Both groups were prescribed a two-gram-per-day sodium-restricted diet and were provided with standardized nutrition education materials
  • The patients in the dietitian education group received two individualized nutrition-counseling appointments with a registered dietitian
  • Study end points were collected three months after randomization.


Two individualized nutrition-counseling appointments with a registered dietitian. 

Statistical Analysis

  • Baseline comparisons were performed with T-tests and x2
  • Within- and between-group comparisons of the impact of dietitian counseling were perfomed using a two-way repeated-measures analysis of variance and the Student-Newman-Keuls post-hoc comparison
  • All data are expressed as mean ±SE
  • All statistical analyses were performed using SigmaStat, version 1.0
  • A P-value of below 0.05 was accepted as significant. 
Data Collection Summary:

Timing of Measurements

Three months after randomization.

Dependent Variables

  •  Change in dietary sodium assessed by three-day food records
  •  Intake of dietary fluid, energy, carbohydrate, protein and fat assessed by three-day food records
  •  Weight, diuretic dose and blood pressure. No description given of how these were measured.

Independent Variables

Counseling with a registered dietitian.

Description of Actual Data Sample:
  • Initial N: 50 (35 males, 12 females, three unknown)
  • Attrition (final N): 47 (35 males, 12 females)
  • Age: 56±3 years for the intervention group; 61±3 years for the control group
  • Ethnicity: Not described
  • Other relevant demographics: All participants were patients at an ambulatory clinic in Toronto, Canada.


  • LVEF of 22±2% and 23±2% and furosemide dosage of 82±13mg and 90±12mg per day for intervention and control groups, respectively
  • The intervention group had 12 with coronary disease and 11 with non-ischemic cardiomyopathy
  • The control group had 9 with coronary disease and 13 were not described
  • Weight, serum sodium, systolic and diastolic blood pressure and heart rate were not different
  • Dietary intake of sodium, fluid, energy, carbohydrate, protein and fat was not significantly different. 


Toronto, Canada.

Summary of Results:

After Three Months


Treatment Group
(Measures and Confidence Intervals)

Control Group
(Measures and Confidence Intervals)

Statistical Significance of Group Difference

Sodium Intake (g/d)




Fluid Intake (L/d)




Energy Intake (kJ/d)




Carbohydate (g/d)




Protein (g/d)




Fat (g/d)




Weight (kg)




Serum Sodium (mmol/L)




BP Systolic (mmHg)




BP Diastolic (mmHg)




Heart Rate (BPM)




Other Findings

  • There was a trend for reduced blood pressure in the intervention group at three months that did not achieve statistical significance
  • No patient in either group required any adjustment in furosemide or other medical theapy during the course of this study.
Author Conclusion:

These results provide evidence for the role of a dietitan as part of the HF multidisciplinary team in helping patients achieve and adhere with a sodium-restricted diet. 

Funding Source:
Reviewer Comments:

While this study showed that intervention by an RD is effective in helping patients to lower their sodium intake, it did not show any clinical benefits of this change for the patient.  

Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) No
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) No
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? No
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? No
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? ???
  7.5. Was the measurement of effect at an appropriate level of precision? ???
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes