Heart Failure, CongestivePhase 2NCT00001402
PET Scan to Determine Areas of Blood Flow and Activity in the Hearts of Patients With Heart Disease Taking Beta-Blockers
A Phase 2 study testing PET scan in people with Heart Failure, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
The human heart is divided into four chambers. One of the four chambers, the left ventricle, is the chamber mainly responsible for pumping blood out of the heart into the circulation. Diseases of the heart like congestive heart failure (CHF), can cause the left ventricle to function improperly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- PET scan
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1994to Mar 2001
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Left ventricular ejection fraction by radionuclide angiography of less than or equal to 40%.
New York Heart Association class II, III or IV symptoms on standard heart failure medications which my include digoxin, diuretics and angiotensin converting enzyme inhibitors for at least one month prior to enrollment.
Ischemic cardiomyopathy if enzymes document an MI or 70% or greater stenosis in one major vessel.
Dilated cardiomyopathy-if no coronary disease.
No pregnant or lactating women.
No women of child-bearing age not on proven birth control.
No severe hepatic or renal disease.
No diabetes mellitus or fasting glucose greater than or equal to 120 mg/dl.
No primary valvular heart disease.
No PTCA or CABG within 3 months of enrollment.
No history of myocardial infarction or unstable angina within past 2 months.
No resting heart rate less than 60 bpm.
No A-V block greater than 1 degree block without pacemaker.
No severe ETOH abuse within 6 months of enrollment.
No severe bronchospasm.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Assessment of Metabolic Function and Perfusion Using Positron Emission Tomography: An Analysis of Patients With Congestive Cardiomyopathy Before and After Beta-Blockers
The human heart is divided into four chambers. One of the four chambers, the left ventricle, is the chamber mainly responsible for pumping blood out of the heart into the circulation. Diseases of the heart like congestive heart failure (CHF), can cause the left ventricle to function improperly.
Medications called beta-blockers appear to reverse the abnormalities in the left ventricle and frequently improve the function of the left ventricle in patients with different kinds of heart disease. How beta-blockers improve left ventricle function is unknown.
Read more
One possible reason for improved function of the left ventricle with beta-blockers is improved blood flow to the heart muscle. When a region of the heart is active, it uses more fuel in the form of oxygen and sugar (glucose). As heart activity increases, blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive sugar (glucose) and positron emission tomography (PET) scans to observe what areas of the heart are receiving more blood flow.
In this study researchers plan to measure glucose use in heart muscle and blood flow to the heart muscle in patients with CHF taking beta-blockers.
Read the detailed description
Deterioration in left ventricular function, which is characteristic in patients with congestive heart failure, appears to be a multifactorial process. Beta-blockers appear to reverse the deterioration and frequently improve left ventricular function in patients with both ischemic and non-ischemic cardiomyopathies. The mechanism by which beta-blockers improve ejection fraction is not known. Although it is well established that regional flow, function and metabolism may improve after coronary revascularization whether beta-blocker therapy will have similar salutary results in patients with congestive heart failure is unknown. The aim of this study is to: 1) quantitate regional glucose uptake and regional blood flow before and after chronic beta-blocker administration to patients with congestive heart failure using positron emission tomography, 2) determine if alteration in either regional glucose or lipid uptake or regional blood flow correlate with improvement in wall motion and global left ventricular function, and 3) determine if ischemic and nonischemic myocardium differ in blood flow or metabolism.
- Conditions
- Heart Failure, Congestive
- Being tested
- PET scan
- Keywords
- Dilated Cardiomyopathy, Hibernating Myocardium, Ischemic Cardiomyopathy, Metoprolol, Stress Thallium Scintigraphy, Congestive Cardiomyopathy, Congestive Heart Failure, Heart Failure
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJan 1994
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 130 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001402
- Sponsor's protocol ID
- 940054
- Other IDs
- 94-H-0054
- Status last verified
- Dec 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Eichhorn EJ, Heesch CM, Barnett JH, Alvarez LG, Fass SM, Grayburn PA, Hatfield BA, Marcoux LG, Malloy CR. Effect of metoprolol on myocardial function and energetics in patients with nonischemic dilated cardiomyopathy: a randomized, double-blind, placebo-controlled study. J Am Coll Cardiol. 1994 Nov 1;24(5):1310-20. doi: 10.1016/0735-1097(94)90114-7.
PubMed 7930255Kjekshus JK, Mjos OD. Effect of free fatty acids on myocardial function and metabolism in the ischemic dog heart. J Clin Invest. 1972 Jul;51(7):1767-76. doi: 10.1172/JCI106978.
PubMed 5032525
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
- Assessment of Metabolic Function and Perfusion Using Positron Emission Tomography: An Analysis of Patients With Congestive Cardiomyopathy Before and After Beta-Blockers
- ClinicalTrials.gov ID
- NCT00001402
- Acronym / sponsor ID
- 940054
- Conditions
- Heart Failure, Congestive
- Keywords
- Dilated Cardiomyopathy, Hibernating Myocardium, Ischemic Cardiomyopathy, Metoprolol, Stress Thallium Scintigraphy, Congestive Cardiomyopathy, Congestive Heart Failure, Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1994
- Study completion
- Mar 2001
- First posted
- 10 Dec 2002 (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.
The human heart is divided into four chambers. One of the four chambers, the left ventricle, is the chamber mainly responsible for pumping blood out of the heart into the circulation. Diseases of the heart like congestive heart failure (CHF), can cause the left ventricle to function improperly.
Medications called beta-blockers appear to reverse the abnormalities in the left ventricle and frequently improve the function of the left ventricle in patients with different kinds of heart disease. How beta-blockers improve left ventricle function is unknown.
One possible reason for improved function of the left ventricle with beta-blockers is improved blood flow to the heart muscle. When a region of the heart is active, it uses more fuel in the form of oxygen and sugar (glucose). As heart activity increases, blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive sugar (glucose) and positron emission tomography (PET) scans to observe what areas of the heart are receiving more blood flow.
In this study researchers plan to measure glucose use in heart muscle and blood flow to the heart muscle in patients with CHF taking beta-blockers.
Detailed description
Deterioration in left ventricular function, which is characteristic in patients with congestive heart failure, appears to be a multifactorial process. Beta-blockers appear to reverse the deterioration and frequently improve left ventricular function in patients with both ischemic and non-ischemic cardiomyopathies. The mechanism by which beta-blockers improve ejection fraction is not known. Although it is well established that regional flow, function and metabolism may improve after coronary revascularization whether beta-blocker therapy will have similar salutary results in patients with congestive heart failure is unknown. The aim of this study is to: 1) quantitate regional glucose uptake and regional blood flow before and after chronic beta-blocker administration to patients with congestive heart failure using positron emission tomography, 2) determine if alteration in either regional glucose or lipid uptake or regional blood flow correlate with improvement in wall motion and global left ventricular function, and 3) determine if ischemic and nonischemic myocardium differ in blood flow or metabolism.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| PET scan | Device | – |
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 4 Mar 2008.
- Background: PubMed 7930255Eichhorn EJ, Heesch CM, Barnett JH, Alvarez LG, Fass SM, Grayburn PA, Hatfield BA, Marcoux LG, Malloy CR. Effect of metoprolol on myocardial function and energetics in patients with nonischemic dilated cardiomyopathy: a randomized, double-blind, placebo-controlled study. J Am Coll Cardiol. 1994 Nov 1;24(5):1310-20. doi: 10.1016/0735-1097(94)90114-7.
- Background: PubMed 5032525Kjekshus JK, Mjos OD. Effect of free fatty acids on myocardial function and metabolism in the ischemic dog heart. J Clin Invest. 1972 Jul;51(7):1767-76. doi: 10.1172/JCI106978.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET scan in people with Heart Failure, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
On the ClinicalTrials.gov record for NCT00001402, which also lists 2 linked publications.
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.