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Ventricular-Vascular Coupling in Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207220
First Posted: September 21, 2005
Last Update Posted: November 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brigham and Women's Hospital
  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.

Condition Intervention
Heart Failure With Preserved Ejection Fraction Procedure: arterial tonometry Procedure: echocardiography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ventricular-Vascular Coupling in Patients With Heart Failure and Preserved Ejection Fraction

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Enrollment: 53
Study Start Date: January 2004
Study Completion Date: January 2007
Groups/Cohorts Assigned Interventions
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 Name: PAT
Procedure: echocardiography
ultrasound test using sound waves to create a moving picture of the heart
Other Name: cardiac echo

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
adults with heart failure and preserved left ventricular function
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207220


Locations
United States, Massachusetts
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
  More Information

ClinicalTrials.gov Identifier: NCT00207220     History of Changes
Other Study ID Numbers: 2003P-001769
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: November 9, 2007
Last Verified: November 2007

Keywords provided by Brigham and Women's Hospital:
heart failure
preserved ejection fraction
vascular stiffness

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases