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

N/A

Waitlist Available

Led By Scott L. Hummel, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Veterans aged 45 years with HTN here defined as screening systolic BP 130 and/or diastolic BP 85 mmHg, or current use of anti-hypertensive drugs and metabolic syndrome body mass index 30 kg/m2 and/or waist circumference >94 cm

Be older than 18 years old

Must not have

Hepatic disease, e.g.: cirrhosis

Chronic kidney disease with estimated glomerular filtration rate <45 ml/min/ 1.73m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase 2 of study, months 1 and 6

Summary

This trial will test whether a low-sodium, high-quality dietary pattern can prevent HFpEF in Veterans at risk for this condition.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include initial discomforts such as cravings or hunger due to new food habits. However, no significant medical side effects are expected from adopting the DASH/SRD diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a liver condition like cirrhosis.

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

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I have an aortic aneurysm that needs surgery.

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I do not have any other health conditions that would limit my life expectancy to less than 12 months.

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My diabetes is not well-controlled, with an A1c over 10%.

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I do not require oxygen for severe lung problems.

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I have had high potassium levels that needed immediate treatment.

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I have a history of heart failure.

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I have moderate or severe heart valve disease.

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I have cancer other than non-melanoma skin cancer or low-risk prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase 2 of study, months 1 and 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase 2 of study, months 1 and 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 2 of study, months 1 and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Left ventricular mass index

Secondary study objectives

Carotid-femoral pulse wave velocity

Global left atrial strain

Global longitudinal left ventricular strain

+2 more

Other study objectives

24-hour urinary sodium excretion

Salt-sensitivity phenotype

Sodium-restricted DASH diet adherence

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Motivational Interviewing + WHEELS-IExperimental Treatment1 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 DietExperimental Treatment1 Intervention

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

Group III: Motivational InterviewingActive Control1 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 DietPlacebo Group1 Intervention

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

0 / 11Eligibility criteria met