Ventricular-Vascular Coupling in Heart Failure

Mass General Brigham

Status: Completed

Conditions: Heart Failure With Preserved Ejection Fraction

Treatments: Procedure: echocardiography; Procedure: arterial tonometry

Study type: Observational

Funder types: Other

Identifiers

NCT00207220

2003P-001769

Details and patient eligibility

About

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.

Full 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

Enrollment: 53 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

53 participants in 1 patient group

3

Description:

subjects with heart failure and normal ejection fraction non-diabetic hypertensive controls hypertensive diabetic controls normotensive controls

Treatment:

Procedure: arterial tonometry

Procedure: echocardiography