NCT00001402

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 1994

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1994

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

December 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Dilated CardiomyopathyHibernating MyocardiumIschemic CardiomyopathyMetoprololStress Thallium ScintigraphyCongestive CardiomyopathyCongestive Heart FailureHeart Failure

Interventions

PET scanDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • 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.

    PMID: 7930255BACKGROUND
  • Kjekshus 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.

    PMID: 5032525BACKGROUND

MeSH Terms

Conditions

Heart FailureCardiomyopathy, Dilated

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiomegalyCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

January 1, 1994

Study Completion

March 1, 2001

Last Updated

March 4, 2008

Record last verified: 1999-12

Locations