Expired Study
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Boston, Massachusetts 02115


Purpose:

This study will test the hypothesis that increases in ventricular-vascular stiffness can be demonstrated by arterial tonometry and echocardiography in subjects with heart failure with preserved ejection fraction (HF-nlEF)(i.e. normal left ventricular function.) We will also track changes in pulsatile hemodynamics over time in subjects hospitalized with HF-nlEF.


Study summary:

The pathophysiologic mechanisms responsible for the development of heart failure in people with preserved ejection fraction (i.e. normal left ventricular function) remain poorly understood. One possible mechanism may be the contribution of increased arterial stiffness to changes in pulsatile hemodynamic load during ventricular systole, implicating abnormal ventricular-vascular interactions throughout the cardiac cycle in the pathogenesis of heart failure with normal ejection fraction. To investigate changes in ventricular-vascular stiffness in subjects with heart failure and normal left ventricular function, comparisons will be made between 3 distinct sub-populations: - subjects with heart failure and normal ejection fraction - non-diabetic hypertensive controls - normotensive controls


Criteria:

Inclusion Criteria: Subjects with heart failure and preserved ejection fraction - clinical signs of heart failure - serum brain natriuretic peptide (BNP) >100pg/mL - NYHA functional class II-IV - left ventricular ejection fraction(LVEF) >=50% measured by echocardiography - Non-diabetic subjects with hypertension - treated or untreated essential hypertension - LVEF >=50% measured by echocardiography Diabetic subjects with hypertension - Type 2 diabetes - treated or untreated essential hypertension - LVEF >=50% measured by echocardiography Normotensive control subjects - normal blood pressure (i.e. < 140/90 mmHg) - LVEF >=50% measured by echocardiography Exclusion Criteria: Subjects with heart failure and preserved ejection fraction - atrial fibrillation - symptoms of angina or a myocardial infarction (MI) within 6 months - known significant coronary artery disease (CAD) (stenosis > 70%) - significant valvular heart disease - restrictive/constrictive heart disease - inability to lie flat for procedure (estimated duration 1 hour) Non-diabetic subjects with hypertension - atrial fibrillation - symptoms of angina or a myocardial infarction (MI) within 6 months - known significant coronary artery disease (CAD) (stenosis > 70%) - significant valvular heart disease - restrictive/constrictive heart disease - inability to lie flat for procedure (estimated duration 1 hour) - prior history of heart failure or unexplained dyspnea Diabetic subjects with hypertension - atrial fibrillation - symptoms of angina or a myocardial infarction (MI) within 6 months - known significant coronary artery disease (CAD) (stenosis > 70%) - significant valvular heart disease - restrictive/constrictive heart disease - inability to lie flat for procedure (estimated duration 1 hour) - prior history of heart failure or unexplained dyspnea Normotensive control subjects - prior history of structural heart disease or ventricular hypertrophy - treatment with HMG-Co(A)reductase inhibitors (statins) - anti-hypertensive medications - cigarette smoking - cocaine use - excessive alcohol intake


NCT ID:

NCT00207220


Primary Contact:

Principal Investigator
Mark Creager, M.D.
Brigham and Women's Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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