Heart Failure, Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
DASH Diet, Low socioeconomic status, HFPEF
Brief summary
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.
Detailed 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).
Interventions
OTHERDASH Diet
12 Weeks of isocaloric DASH diet \<2300 mg Na/day using meals (lunch, dinner, snacks) prepared by the Wake Forest Clinical Research Metabolic Kitchen under the direction of a registered dietician (RD). 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.
OTHERUsual diet
12 weeks usual diet \<2300 mg Na/day
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of enrolled participants per week | Up to week 12 |
| Proportion of participants that adhere to the to intervention | Up to week 12 |
| Number participants that were retained in the trial | Up to week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants that adhere to the diet | Up to week 12 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body mass Index (BMI) | Baseline | — |
| IL6 | Baseline | Inflammatory marker |
| Systolic Blood Pressure | Baseline | — |
| Diastolic Blood Pressure | Baseline | — |
| Total Cholesterol | Baseline | — |
| LDL Cholesterol | Baseline | — |
| TNF alpha | Baseline | Inflammatory marker |
| Doppler echocardiogram velocity ratio | Baseline | — |
| serum creatinine | Baseline | — |
| Serum creatinine | After intervention, Week 12 | — |
| Left Ventricle mass | Baseline | Doppler-echocardiograms |
| Left atrial volume | Baseline | Doppler-echocardiograms |
| 6- minute walk test | Baseline | Exercise capacity. 6- minute walk test (6 MWT) by the method of Guyatt 43. Percent predicted for age and gender. |
| Plasma nitrate | Baseline | — |
| HDL Cholesterol | Baseline | — |
| CRP | Baseline | Inflammatory marker |
| Weight | Baseline | Weight (kilograms) |
| Waist circumference | Baseline | Waist circumference (cm) |
Countries
United States
Outcome results
None listed