Low-Sodium, High-Quality Diet for Heart Failure Prevention

Overseen By Scott L. Hummel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Antihypertensives

Disqualifiers: Heart failure, Stroke, Cancer, others

Compensation: Varies

Number of Visits: 2

81 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Scott L. Hummel, MD

Principal Investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

Eligibility Criteria

This trial is for Veterans aged 45+ with high blood pressure and metabolic syndrome, which includes obesity or a large waist size. They must be willing to use a smartphone app or email for the WHEELS-I program. It's not open to those with recent heart attacks, uncontrolled diabetes, severe heart conditions, very high blood pressure, certain past illnesses like HFpEF, or who are in other studies.

Inclusion Criteria

I am a veteran aged 45 or older with high blood pressure or on blood pressure medication, and I am overweight.

Participants must also be willing to participate in the WHEELS-I program by using a smartphone application or email

Exclusion Criteria

I have a liver condition like cirrhosis.

Your blood pressure is higher than 160 mmHg when you are checked before starting the treatment.

My kidney function is low, with a filtration rate under 45 ml/min.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Crossover-Randomized Diet Comparison

Participants undergo a crossover-randomized comparison of DASH/SRD vs. control diet for two weeks each to evaluate salt-sensitivity.

4 weeks

2 visits (in-person)

Phase 2: DASH/SRD Adherence Promotion

Participants engage in a 6-month extension to promote DASH/SRD adherence, including motivational interviewing and tailored messaging.

6 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention.

4 weeks

Treatment Details

Interventions

• Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors
• Performance of WHEELS-I in promoting DASH/SRD adoption

Trial Overview The study tests if following a special diet called DASH/SRD can prevent heart failure in people at risk. Participants will either adopt this healthy eating plan that reduces salt intake and improves overall diet quality or follow their usual diet as control for comparison.

Participant Groups

Group I: Motivational Interviewing + WHEELS-I Experimental Treatment 1 Intervention

In addition to motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan., participants in this arm will also receive an electronically-delivered tailored messaging intervention called Women's and Men's Hypertension Experiences and Emerging Lifestyle Intervention (WHEELS-I).

Group II: DASH/SRD Diet Experimental Treatment 1 Intervention

Participants in this arm will receive prepared, pre-packaged meals containing 1150mg of sodium.

Group III: Motivational Interviewing Active Control 1 Intervention

Participants in this arm will receive motivational interviewing-based counseling with a registered dietitian to promote adoption of the sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan.

Group IV: Control Diet Placebo Group 1 Intervention

Participants in this arm will receive prepared, pre-packaged meals containing 5750mg of sodium.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+