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



Status:Terminated
Conditions:High Blood Pressure (Hypertension), Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:50 - Any
Updated:6/8/2018
Start Date:September 18, 2012
End Date:February 16, 2016

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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.

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
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Scott L Hummel, MD MS
Phone: 734-764-7440
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
from
Ann Arbor, MI
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