Ventricular-Vascular Coupling in Heart Failure

NCT00207220 | Completed

• 1 other identifier: 2003P-001769
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

heart failure; preserved ejection fraction; vascular stiffness

Study Arms (1)

3

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

Procedure: arterial tonometry; Procedure: echocardiography

Interventions

arterial tonometry PROCEDURE

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

Also known as: PAT

3

echocardiography PROCEDURE

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

Also known as: cardiac echo

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adults with heart failure and preserved left ventricular function

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mark Creager, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Akshay S. Desai, M.D.

  Brigham and Women's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2004
• Study Completion: January 1, 2007
• Last Updated: November 9, 2007

Record last verified: 2007-11

Locations

US (1)