Trials are Needed to Evaluate Nutrition Interventions for HF: Analysis of the Federal Nutrition and HF Research Portfolio

Abstract

Background: Nutrition research has the potential to identify better ways of preventing andmanaging heart failure, leading to reduced costs and better patient outcomes. However, it has proved especially challenging to design well-powered clinical efficacy and ffectiveness studies in this field.Methods: To better understand the federal heart failure-related research support provided to date, and to identify issues that must be addressed by applicants, we present the results of a portfolio analysis based on search results from the Federal RePORTER database. The search was limited to funded projects for the fiscal years 2000-2014 where the terms “nutrition or diet or dietary supplements” and “heart failure” were included in the abstract, key words, or title. Results: Approximately 60 projects were funded during this time period, themajority being supported through research project grants (R mechanisms) and a smaller number through training awards (F or K mechanisms). Most of the support was provided by three NIH Institutes (NHLBI, NINR, and NIA) and by the Office of Dietary Supplements. The main types of funded science were basic studies in animal models, mechanistic physiology studies in humans, and longitudinal or cross-sectional observational cohort studies. Therewere relatively few intervention studies, withmost evaluating behavioral change and education modalities. The trials that compared dietary treatments generally were small proof-of-concept or pilot studies. Nutrition research typically comprises w5% of the NIH research investment in most years (for example, $1.6B/$30B in 2014); heart failure has a very low profile within the NIH nutrition research portfolio (for example, approximately $4M/$1.6B, or 0.2% in 2014). Conclusion: Nutrition issues and diet interventions are understudied in heart failure patients. All types of research are needed, particularly well-designed clinical efficacy and effectiveness trials. Submission strategies and funding opportunities that can be considered for closing data gaps related to the ongoing epidemic of heart failure will be discussed.