Ventricular-Vascular Coupling in Heart Failure

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00207220

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction	Procedure: arterial tonometry Procedure: echocardiography

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

Study Design

Study Type:

Observational

Actual Enrollment :

53 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2004

Actual Study Completion Date :

Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
3 subjects with heart failure and normal ejection fraction non-diabetic hypertensive controls hypertensive diabetic controls normotensive controls	Procedure: arterial tonometry used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger. Other Names: PAT Procedure: echocardiography ultrasound test using sound waves to create a moving picture of the heart Other Names: cardiac echo

Arm

Intervention/Treatment

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

Procedure: arterial tonometry

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

Other Names:

PAT

Procedure: echocardiography

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

Other Names:

cardiac echo

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator: Mark Creager, M.D., Brigham and Women's Hospital
Study Director: Akshay S. Desai, M.D., Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00207220

Other Study ID Numbers:

2003P-001769

First Posted:

Sep 21, 2005

Last Update Posted:

Nov 9, 2007

Last Verified:

Nov 1, 2007

Keywords provided by , ,

heart failure

preserved ejection fraction

vascular stiffness

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Nov 9, 2007