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Low-sodium diet may benefit after HF hospitalization
Although adherence to a provided diet was low, patients who were recently hospitalized for HF and adhered to a low-sodium diet had reductions in urinary sodium without an effect on quality of life, according to results of the PROHIBIT pilot study published in Circulation: Heart Failure.
“This study was done to inform how to develop the pivotal trial to answer the question whether a low-salt diet is beneficial, neutral or harmful in patients with heart failure, as current data have shown varied results,” Cardiology Today Editorial Board Member Javed Butler, MD, MPH, MBA, FACC, FAHA, professor and chairman of the department of medicine at the University of Mississippi Medical Center, told Healio. “We specifically targeted higher-risk patients on standard-of-care therapy.”
Diet after HF hospitalization
Andreas Kalogeropoulos, MD, MPH, PhD, associate professor of medicine in the division of cardiology at State University of New York at Stony Brook, and colleagues analyzed data from 27 patients (mean age, 62 years; 81% men) with HF and left ventricular ejection fraction no greater than 40% who were on optimal guideline-recommended therapy. Patients had been recently hospitalized and were discharged within 2 weeks before enrollment, and had 24-hour urine sodium levels of at least 3,000 mg.
Patients were assigned prepared meals with daily sodium content of either 1,500 mg (n = 12) or 3,000 mg (n = 15) for 12 weeks. Compliance to the provided meals was reinforced at each interaction. Follow-up was conducted for 12 weeks after the intervention by phone call and a clinic visit.
The primary endpoint was on-study retention. A secondary endpoint was a composite of hospitalization and mortality.
At 12 weeks, on-study retention was 77%, and six patients withdrew from the study before completion. Both diets were well-tolerated according to food satisfaction questionnaires.
“In order to not rely on patients’ ability to cook foods with appropriate amount of salt depending on which arm the patient is randomized to, we provided them weekly food,” Butler said in an interview. “The first lesson that we learned was that despite giving free food to participants for this 12-week study, many patients were not interested in only eating the food provided. Also, in the higher-risk post-discharge patients, perhaps due to instructions given during hospitalization, many patients did not meet the baseline sodium intake criteria, and their urinary sodium excretion was less than expected.”
Patients assigned 1,500 mg of sodium per day had improvements in Kansas City Cardiomyopathy Questionnaire summary scores (12 units; P < .001), with no change seen in those assigned 3,000 mg of sodium per day (1 unit; P = .82).
Based on urinary sodium, average compliance with meals was 52%, which did not significantly differ in the 1,500 mg of sodium per day group compared with the 3,000 mg of sodium per day group (42% vs. 60%, respectively; P = .25). Urinary sodium was reduced by 137 mmol in patients assigned 1,500 mg of sodium per day (P < .001) compared with 82 mmol in those assigned 3,000 mg of sodium per day (P < .001), with a between-arms difference of 55 mmol (95% CI, 3-107; P = .037).
Both diets did not affect N-terminal pro-B-type natriuretic peptide, and there were no significant differences between both groups for low BP events and hospitalizations. Patients assigned 1,500 mg of sodium per day had a greater reduction in serum creatinine compared with those assigned 3,000 mg of sodium per day (–0.15 mg/dL vs. 0.02 mg/dL; between-group difference = 0.17; 95% CI, 0.06-0.28; P = .003).
Only one patient assigned 3,000 mg of sodium per day had worsening renal function, defined as a creatinine increase greater than 0.5 mg/dL at 24 weeks.
There were no deaths, and five patients in the 1,500 mg group were hospitalized compared with four in the 3,000 mg group.
Challenges to address
“This experience highlights the difficulties in conducting feeding studies and informs challenges that should be planned for when designing the pivotal trial,” Butler told Healio. – by Darlene Dobkowski
For more information:
Javed Butler, MD, MPH, MBA, FACC, FAHA, can be reached at University of Mississippi Medical Center, Department of Medicine, 2500 North State Street, Jackson, MS 39216; jbutler4@umc.edu; Twitter: @javedbutler1.
Disclosures: Butler reports he received research support from the European Union, the NIH and the Patient Centered Outcomes Research Institute; serves on the speaker bureau for Janssen, Novartis and Novo Nordisk; serves as a consultant and on clinical events committees, data safety monitoring boards or steering committees for Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, BerlinCures, Boehringer Ingelheim, Bristol-Myers Squibb, CardioCell, CVRx, G3 Pharmaceutical, Innolife, Janssen, Lantheus, LivaNova, Luitpold, Medtronic, Merck, Relypsa, Roche, Sanofi, StealthPeptide, SC Pharma, V-Wave Limited, Vifor and ZS Pharma. Kalogeropoulos reports he received research support from the American Heart Association, American Society of Echocardiography, CDC, Critical Diagnostics and the NHLBI. All other authors report no relevant financial disclosures.