Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)

N/ATerminatedNCT01942395

University of Michigan18 enrolled

Overview

The purpose of this study is to examine how dietary changes affect the heart and blood vessels in patients with hypertension (high blod pressure) who have a condition called 'heart failure with preserved ejection fraction" (HFPEF). This condition is also known as "diastolic heart failure" or "heart failure with normal ejection fraction", and occurs even though the heart's pumping function is normal.

In an earlier study, the investigators found that patients with HFPEF who ate a special diet for three weeks had improved blood pressure control and lower levels of blood chemicals that may damage the heart and blood vessels. The eating plan in the study was based on the DASH diet, also known as the Dietary Approaches to Stop Hypertension diet. This plan is rich in fruits, vegetables, and low-fat dairy, and is recommended to decrease blood pressure in patients with hypertension. Current medical guidelines also recommend that both patients with hypertension and those with heart failure should decrease their dietary salt intake. The diets that patients will eat in this study are the DASH/sodium-restricted (DASH/SRD) diet as well as a control diet based on the average reported diet collected using Food Frequency Questionnaires during our pilot study. Patients will be randomized to one diet for three weeks and then crossover to the other diet for three weeks. Patients will then be asked to eat the DASH/sodium-restricted diet on their own at home with dietary support for an additional eight weeks. In this study, the main goal is to confirm the findings of our earlier study. The investigators would also like to understand how the DASH/SRD changes the function of the heart and blood vessels during exercise and the activity of genes that could be involved in HFPEF.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diastolic Heart Failure Hypertensive Heart Disease

Interventions

DASH/sodium-restricted diet (DASH/SRD)BEHAVIORAL

Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. The target sodium content will be 1,500 mg/2,100 kcal, as per recent American Heart Association population recommendations for sodium intake. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the 21 days urinary sodium, potassium, and 8-isoprostanes will again be measured.

Control DietBEHAVIORAL

The Control Diet will be patterned on the information we collected using Food Frequency Questionnaires during our pilot study HUM00025253 (i.e., the dietary patterns reported by previously recruited hypertensive HFPEF patients). The target sodium content will be 3,500 mg per 2,100 kcal and target potassium content for the control diet will be 2,000 mg per 2,100 kcal.

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Symptoms and/or signs of HFPEF in the past 12 months * Most recent LVEF ≥ 50% (contrast ventriculography, echocardiography, nuclear scintigraphy) * Diastolic dysfunction on previous echocardiogram/catheterization or evidence of abnormal neurohormonal activation (B-type natriuretic peptide (BNP) ≥ 100 pg/ml) * History of systemic hypertension * Willing to adhere to provided diet Exclusion Criteria: * NYHA Class IV heart failure symptoms * Hospitalization for decompensated HF within past one month * Uncontrolled hypertension (seated SBP ≥ 180 or DBP ≥ 110) at rest, on current antihypertensive regimen * Changes in medical regimen for heart disease or hypertension within past 1 month, except diuretic dose adjustment (within past 1 week) * Previous LVEF \< 40% * Primary exercise limitation due to severe pulmonary disease * Uninterpretable echocardiographic windows * Worse than moderate mitral or aortic stenosis or insufficiency. * Baseline serum potassium level \> 5.0 mmol/L or prior history of potassium \> 6.0 * Serum calcium/phosphorus product \> 50 at baseline * Severe renal insufficiency (current estimated GFR \< 30 ml/min) * Severe anemia (Hgb \< 9 g/dL) * Severely uncontrolled diabetes mellitus (Hgb A1C \> 10%) * Non-hypertension related cause of HFPEF (e.g. amyloidosis, sarcoidosis, constrictive pericardial syndromes, primary hypertrophic or restrictive cardiomyopathy) * Primary right ventricular failure * Myocardial infarction or unstable angina, including new or worsening anginal syndrome, within the past three months * Uncontrolled arrhythmia (including non rate-controlled atrial fibrillation) * Terminal illness expected to result in death within six months * Psychiatric disorder or dementia with potential to compromise dietary adherence

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Urinary F2-Isoprostanes

Time frame: The change from Baseline in Urinary F2-Isoptorstanes at Week 3, Week 6, and Week 14

Secondary Outcomes

24-hour ambulatory blood pressure (mean and diurnal variation)

Time frame: The change from Baseline in 24-hour blood pressure at Week 3, Week 6, and Week 14

Carotid-femoral pulse wave velocity

Time frame: The change from Week 3 in Carotid-femoral pulse wave velocity at Week 6, and Week 14

Six minute walk test distance

Time frame: The change from Baseline in six minute walk test distance at Week 3, Week 6, and Week 14

Estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus product

Time frame: The change from Baseline in estimated glomerular filtration rate, serum potassium, serum calcium-phosphorus distance at Week 3, Week 6, and Week 14

Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise)

Time frame: The change from Week 3 in Echocardiographic ventricular systolic and diastolic function (resting), ventricular-vascular coupling (resting and during bicycle ergometer exercise) at Week 6, and Week 14

Knowledge, skills and attitudes related to DASH/SRD

Will be assessed using the Dietary Sodium Restriction and the PACE questionnaires

Time frame: Change from the screening visit in knowledge, skills and attitudes related to DASH/SRD to Week 6

Pro-oxidant and pro-inflammatory gene activation in peripheral mononuclear cells and venous endothelial cells

Data from ClinicalTrials.gov

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