PET Scan to Determine Areas of Blood Flow and Activity in the Hearts of Patients With Heart Disease Taking Beta-Blockers

March 3, 2008 updated by: National Heart, Lung, and Blood Institute (NHLBI)

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Heart, Lung and Blood Institute (NHLBI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1994

Study Completion

March 1, 2001

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

December 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 940054
  • 94-H-0054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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