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Completed

NCT Number: NCT00207220

Ventricular-Vascular Coupling in Heart Failure

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arterial tonometry

Procedure

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

Other names: PAT

Echocardiography

Procedure

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

Other names: cardiac echo

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Nov 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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