Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome

NCT03170375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-09-10

Study results available
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Summary

Tens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.

Conditions

Interventions

BEHAVIORAL

Performance of WHEELS-I in promoting DASH/SRD adoption

All participants will receive motivational interviewing (MI) based counseling. Participants in the MI + WHEELS-I arm will also receive the WHEELS-I electronically-delivered tailored messaging.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Scott L. Hummel, MD · VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2024-03-31
Completion
2025-01-23

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03170375 on ClinicalTrials.gov