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Ventricular-Vascular Coupling in Heart Failure

Ventricular-Vascular Coupling in Patients With Heart Failure and Preserved Ejection Fraction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00207220
Enrollment
53
Registered
2005-09-21
Start date
2004-01-31
Completion date
2007-01-31
Last updated
2007-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

heart failure, preserved ejection fraction, vascular stiffness

Brief summary

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.

Detailed description

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

Interventions

used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger.

PROCEDUREechocardiography

ultrasound test using sound waves to create a moving picture of the heart

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026