Clinical trial NCT04113291: Randomized Controlled Pilot Trial of DASH Feeding in Older Low Socioeconomic Adults Without Heart Failure
Official title: Randomized Controlled Pilot Trial of Dietary Approached to Stop Hypertension (DASH) Feeding in Older Low Socioeconomic Adults Without Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Heart Failure With Preserved Ejection Fraction
Keywords: DASH Diet
Low socioeconomic status
HFPEF
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of enrolled participants per week
timeFrame: Up to week 12
measure: Proportion of participants that adhere to the to intervention
timeFrame: Up to week 12
measure: Number participants that were retained in the trial
timeFrame: Up to week 12
Secondary outcomes:
measure: Proportion of participants that adhere to the diet
timeFrame: Up to week 12
Other outcomes:
measure: Weight
timeFrame: Baseline
measure: Weight
timeFrame: After intervention, Week 12
measure: Waist circumference
timeFrame: Baseline
measure: Waist circumference
timeFrame: After intervention, Week 12
measure: Body mass Index (BMI)
timeFrame: Baseline
measure: Body mass Index (BMI)
timeFrame: After intervention, Week 12
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Systolic Blood Pressure
timeFrame: After intervention, Week 12
measure: Diastolic Blood Pressure
timeFrame: Baseline
measure: Diastolic Blood Pressure
timeFrame: After intervention, Week 12
measure: Total Cholesterol
timeFrame: Baseline
measure: LDL Cholesterol
timeFrame: Baseline
measure: HDL Cholesterol
timeFrame: Baseline
measure: serum creatinine
timeFrame: Baseline
measure: Total Cholesterol
timeFrame: After intervention, Week 12
measure: LDL Cholesterol
timeFrame: After intervention, Week 12
measure: HDL Cholesterol
timeFrame: After intervention, Week 12
measure: Serum creatinine
timeFrame: After intervention, Week 12
measure: Left Ventricle mass
timeFrame: Baseline
measure: Left Ventricle mass
timeFrame: After intervention, Week 12
measure: Left atrial volume
timeFrame: Baseline
measure: Left atrial volume
timeFrame: After intervention, Week 12
measure: Doppler echocardiogram velocity ratio
timeFrame: Baseline
measure: Doppler echocardiogram velocity ratio
timeFrame: After intervention, Week 12
measure: CRP
timeFrame: Baseline
measure: IL6
timeFrame: Baseline
measure: TNF alpha
timeFrame: Baseline
measure: CRP
timeFrame: After intervention, Week 12
measure: IL6
timeFrame: After intervention, Week 12
measure: TNF alpha
timeFrame: After intervention, Week 12
measure: 6- minute walk test
timeFrame: Baseline
measure: 6- minute walk test
timeFrame: After intervention, Week 12
measure: Plasma nitrate
timeFrame: Baseline
measure: Plasma nitrate
timeFrame: After intervention, Week 12
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Claudia Campos, MD
role: PRINCIPAL_INVESTIGATOR
References: