Completed

Assessment of Metabolic Function and Perfusion Using Positron Emission Tomography: An Analysis of Patients With Congestive Cardiomyopathy Before and After Beta-Blockers

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What is being tested

PET scan

Device
Who is being recruted

Laminopathies+6

+ Cardiovascular Diseases

+ Heart Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 1994
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00001402
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LaminopathiesCardiovascular DiseasesHeart DiseasesCardiomegalyCardiomyopathiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornCardiomyopathy, DilatedHeart Failure

Criteria

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps
CompletedOne Study Center