Status:
COMPLETED
Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet in Diastolic Heart Failure
Lead Sponsor:
University of Michigan
Conditions:
Diastolic Heart Failure
Hypertensive Heart Disease
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Heart failure with preserved systolic function (HF-PSF, or 'diastolic heart failure') accounts for half of hospitalizations for heart failure in patients over the age of 65. Most HF-PSF patients have ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00939640
Start Date
July 1 2009
End Date
May 1 2011
Last Update
October 15 2019
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109