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CompletedNCT00207220Updated Nov 9, 2007

Ventricular-Vascular Coupling in Heart Failure

An observational study in Heart Failure With Preserved Ejection Fraction, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-11-09.

Sponsored by Brigham and Women's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
53
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Heart Failure With Preserved Ejection Fraction

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Keywords

  • heart failure
  • preserved ejection fraction
  • vascular stiffness
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 53 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

adults with heart failure and preserved left ventricular function

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
53 participants (actual)

Groups and cohorts

  • 3

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

    Procedure: arterial tonometry · Procedure: echocardiography

Interventions

  • Procedurearterial tonometry

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

    Also known as: PAT

  • Procedureechocardiography

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

    Also known as: cardiac echo

06

Study locations

1 site
  • Brigham & Women's Hospital
    Boston, Massachusetts 02115, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00207220
Lead sponsor
Brigham and Women's Hospital
First posted
Sep 21, 2005
Start date
Jan 2004
Completion
Jan 2007
Last update
Nov 9, 2007

Study contacts

Mark Creager, M.D.
principal investigator · Brigham and Women's Hospital
Akshay S. Desai, M.D.
study director · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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