Randomized Controlled Pilot Trial of DASH Feeding in Older Low Socioeconomic Adults Without Heart Failure (DASHF)

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Heart Failure With Preserved Ejection Fraction; Heart Failure

Treatments: Other: DASH Diet; Other: Usual diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04113291

DASHF-PRE

Details and patient eligibility

About

This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention.

Full description

This is a feasibility pilot, randomized clinical trial (RCT), DASH diet feeding trial in 40 older adults. It will also elicit trends in left ventricular remodeling and pathophysiology. This trial investigates the feasibility of performing a DASH diet RCT intervention in HFPEF prevention in older adults of low socioeconomic status (LSES).

Sex: All

Ages: 60 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants will have an education level of less than college as a surrogate marker of LSES.

Exclusion criteria

• Participants should not have a diagnosis of heart failure or loop diuretics on their medication list in the EHR or symptoms of dyspnea, edema (assessed via questionnaire)
• poorly controlled diabetes mellitus ( HBA 1c >9%)
• or uncontrolled hypertension ( SBP>180, DBP>110)
• cardiovascular event (MI, stroke, HF, angina, atrial fibrillation) within the previous six months
• chronic diseases that might interfere with participation (dementia, schizophrenia, dialysis or transplant recipient patients)
• body-mass index (the weight in kilograms divided by the square of the height in meters) of more than 35

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

DASH diet group

Experimental group

Description:

Participants randomized to receive the DASH diet will be prescribed an isocaloric DASH diet using meals (lunch, dinner, snacks) prepared by a Clinical Research Metabolic Kitchen under the direction of a registered dietician. Participants will prepare their own breakfast from a menu. The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day.

Treatment:

Other: DASH Diet

Attention Control Group

Active Comparator group

Description:

Participants randomized to attention control will continue their usual diet, but they will be instructed to limit their sodium intake to 2300 mg/day. They will be requested and voluntarily agree to not make additional diet or exercise changes during the 12-week study.

Treatment:

Other: Usual diet