Heart Failure With Preserved Ejection FractionNCT00207220
Ventricular-Vascular Coupling in Heart Failure
An observational study of Heart Failure With Preserved Ejection Fraction, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- arterial tonometry and echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults with heart failure and preserved left ventricular function
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Ventricular-Vascular Coupling in Patients With Heart Failure and Preserved Ejection Fraction
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
- Being tested
- arterial tonometry, echocardiography
- Keywords
- heart failure, preserved ejection fraction, vascular stiffness
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial tonometryProcedure or surgery
Also called PAT
used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger.
echocardiographyProcedure or surgery
Also called cardiac echo
ultrasound test using sound waves to create a moving picture of the heart
| Study group | Role | What they receive |
|---|---|---|
| 3 | subjects with heart failure and normal ejection fraction non-diabetic hypertensive controls hypertensive diabetic controls normotensive controls Receives: Procedure: arterial tonometry; Procedure: echocardiography |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mark Creager, M.D., Principal investigator, Brigham and Women's HospitalAkshay S. Desai, M.D., Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207220
- Sponsor's protocol ID
- 2003P-001769
- Status last verified
- Nov 2007
- First submitted
- 13 Sep 2005
- Last updated
- 9 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular-Vascular Coupling in Patients With Heart Failure and Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT00207220
- Acronym / sponsor ID
- 2003P-001769
- Keywords
- heart failure, preserved ejection fraction, vascular stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 | – | Procedure: arterial tonometry, Procedure: echocardiographysubjects with heart failure and normal ejection fraction non-diabetic hypertensive controls hypertensive diabetic controls normotensive controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults with heart failure and preserved left ventricular function
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arterial tonometryAlso: PATused to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger. | Procedure or surgery | 3 |
| echocardiographyAlso: cardiac echoultrasound test using sound waves to create a moving picture of the heart | Procedure or surgery | 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2007.
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The Clinical Trial of Tamibarotene for Patients With HFpEF (RELIEF Trial)
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Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
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Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
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Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Creager, M.D. principal investigator
Brigham and Women's Hospital
Akshay S. Desai, M.D. study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2007.