Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet in Diastolic Heart Failure (DASH-DHF)
Diastolic Heart Failure, Hypertensive Heart Disease
About this trial
This is an interventional treatment trial for Diastolic Heart Failure focused on measuring Diet, Sodium, Hypertension, Potassium, Antioxidants, congestive heart failure, Heart failure with normal ejection fraction, Heart failure with preserved systolic function
Eligibility Criteria
Inclusion Criteria:
- Satisfy European Society of Cardiology guidelines for the diagnosis of HF-PSF (Paulus WJ et al. Eur. Heart J. 2007;28:2539-2550).
- Framingham criteria for heart failure satisfied
- left ventricular ejection fraction ≥ 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) with supporting evidence (atrial fibrillation, left atrial enlargement, left ventricular hypertrophy)
- History of systemic hypertension
- Willing to adhere to provided diet
Exclusion Criteria:
- New York Heart Association Class IV heart failure symptoms
- Hospitalization for decompensated heart failure within past one month
- Uncontrolled hypertension (seated systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 110) at rest, on current antihypertensive regimen
- Changes in medical regimen for heart disease or hypertension within past 1 month, including diuretic dose adjustment
- Primary exercise limitation due to severe pulmonary disease
- Poor echocardiographic windows
- Worse than moderate mitral or aortic stenosis or insufficiency.
- Serum potassium level > 5.0 mmol/L at baseline or prior history of serum potassium level > 6.0
- Serum calcium/phosphorus product > 50 at baseline
- Severe renal insufficiency (current estimated glomerular filtration rate < 30 ml/min)
- Severe anemia (hemoglobin < 9 g/dL)
- Uncontrolled diabetes mellitus (hemoglobin A1c > 9%)
- Non-hypertensive cause of HF-PSF, e.g. amyloidosis, sarcoidosis, constrictive pericardial syndromes
- 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 or active solid-organ cancer
- Psychiatric disorder or dementia with potential to compromise dietary adherence
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Experimental
Dietary intervention
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.