Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2004-01-31
2007-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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3
subjects with heart failure and normal ejection fraction non-diabetic hypertensive controls hypertensive diabetic controls normotensive controls
arterial tonometry
used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger.
echocardiography
ultrasound test using sound waves to create a moving picture of the heart
Interventions
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arterial tonometry
used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger.
echocardiography
ultrasound test using sound waves to create a moving picture of the heart
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Principal Investigators
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Mark Creager, M.D.
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Akshay S. Desai, M.D.
Role: STUDY_DIRECTOR
Brigham and Women's Hospital
Locations
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Brigham & Women's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2003P-001769
Identifier Type: -
Identifier Source: org_study_id