Heart Failure, DiastolicNCT00628082
Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure, Diastolic, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial summary
Up to half of all patients with heart failure are found to have normal pumping function of the heart muscle, but show abnormalities in the way the heart muscle relaxes and fills with blood. These patients often have high blood pressure, and tend to have stiff arteries and stiff heart muscle. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Diastolic
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2006to Apr 2009
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Heart Failure Clinic
Who may be able to join
- Clinical features consistent with heart failure
- LVEF ≥ 50%, with no evidence of significant valvular disease, no hypertrophic cardiomyopathy, and no evidence of pericardial constriction
- A peak VO2 < 80% predicted, with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation
Who cannot join
- Objective evidence of lung disease on formal lung function testing
- Reversible myocardial ischaemia on contrast-enhanced myocardial stress
- Echocardiography, and evidence of exercise-induced mitral regurgitation
- Obesity (BMI >35) or a locomotor cause for exercise limitation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Birmingham
Birmingham, B15 2TT
Thanh T Phan, MRCP, 01214145916, ttpquang@hotmail.com
Thanh T Phan, MRCP
About this study
Up to half of all patients with heart failure are found to have normal pumping function of the heart muscle, but show abnormalities in the way the heart muscle relaxes and fills with blood. These patients often have high blood pressure, and tend to have stiff arteries and stiff heart muscle. We wish to test the hypothesis that these patients have abnormal energy stores in their heart muscle.
- Conditions
- Heart Failure, Diastolic
- Keywords
- Cardiac Energetics, Dynamic Diastolic filling Assessment, Heart Failure with Preserved Ejection Fraction, Arterial and Ventricular Stiffening
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HfpEF | Patients with Heart Failure with preserved ejection fraction | |
| Control | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete echocardiographic assessment to assess resting diastolic function
Measured: 1 DAY
Assessment of resting large artery function
Measured: 1 DAY
Multiple Gated Acquisition Scan
Measured: 1 DAY
Cardiac Magnetic Resonance Spectroscopy
Measured: 1 DAY
Metabolic Exercise Testing (VO2max)
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startMar 2006
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- 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
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Heart of England NHS Trust, British Heart Foundation
- Investigators
- Michael Frenneaux, FRCP, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628082
- Sponsor's protocol ID
- RRK 2996
- Status last verified
- Feb 2008
- First submitted
- 24 Feb 2008
- Last updated
- 4 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT00628082
- Acronym / sponsor ID
- RRK 2996
- Conditions
- Heart Failure, Diastolic
- Keywords
- Cardiac Energetics, Dynamic Diastolic filling Assessment, Heart Failure with Preserved Ejection Fraction, Arterial and Ventricular Stiffening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- Heart of England NHS Trust, British Heart Foundation
- Study start
- Mar 2006
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 4 Mar 2008 (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.
Up to half of all patients with heart failure are found to have normal pumping function of the heart muscle, but show abnormalities in the way the heart muscle relaxes and fills with blood. These patients often have high blood pressure, and tend to have stiff arteries and stiff heart muscle. We wish to test the hypothesis that these patients have abnormal energy stores in their heart muscle.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HfpEF | – | –Patients with Heart Failure with preserved ejection fraction |
| Control | – | –Healthy Volunteers |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Failure Clinic
Key inclusion criteria (3 listed)
- Clinical features consistent with heart failure
- LVEF ≥ 50%, with no evidence of significant valvular disease, no hypertrophic cardiomyopathy, and no evidence of pericardial constriction
- A peak VO2 < 80% predicted, with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation
Key exclusion criteria (4 listed)
- Objective evidence of lung disease on formal lung function testing
- Reversible myocardial ischaemia on contrast-enhanced myocardial stress
- Echocardiography, and evidence of exercise-induced mitral regurgitation
- Obesity (BMI >35) or a locomotor cause for exercise limitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete echocardiographic assessment to assess resting diastolic function
Time frame: 1 DAY
Assessment of resting large artery function
Time frame: 1 DAY
Multiple Gated Acquisition Scan
Time frame: 1 DAY
Cardiac Magnetic Resonance Spectroscopy
Time frame: 1 DAY
Metabolic Exercise Testing (VO2max)
Time frame: 1 DAY
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
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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.
Michael Frenneaux, FRCP principal investigator
University of Birmingham
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, Diastolic, run by University Hospital Birmingham at 1 site in United Kingdom.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Mar 2008. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanh T Phan, MRCP (01214145916, ttpquang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete echocardiographic assessment to assess resting diastolic function (time frame: 1 DAY). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 4 Mar 2008.