Effect of Chronic Changes in Heart Rate on Congestive Heart Failure - Full Text View

Effect of Chronic Changes in Heart Rate on Congestive Heart Failure

This study has been completed.

Sponsors and Collaborators:	University of Maryland American Heart Association
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00389649

Purpose

This will be a double blind randomized crossover study of patients with congestive heart failure and a heart rate dependent upon a permanent pacemaker. Thus, at all times the heart rate can be maintained at a set rate by adjusting the settings of the pacemaker. Acute and chronic effects of heart rates of 60, 75, and 90 beats per minute will be evaluated. The effect of heart rate will be determined by measuring ejection fraction by nuclear ventriculography, six minute walk distance, and peak oxygen consumption on a maximal exercise test.

Condition	Intervention
Heart Failure, Congestive	Device: heart rate setting

MedlinePlus related topics:

Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study

Official Title:	Effect of Chronic Changes in Heart Rate on Congestive Heart Failure

Further study details as provided by University of Maryland:

Primary Outcome Measures:

Ejection fraction, six minute walk, peak oxygen consumption

Estimated Enrollment:	24
Study Start Date:	November 2001
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have symptomatic congestive heart failure, NYHA Class II to IV symptoms and an ejection fraction < 40% by nuclear ventriculography within the previous 6 months. Patients must be stable with no change in dosage on conventional therapy (including digoxin, diuretics, ACE inhibitors, hydralazine, nitrates, angiotensin II receptor blockers and/or beta blocker) for at least 4 weeks

Exclusion Criteria:

active alcohol or illicit drug use
myocardial infarction or unstable angina within the previous 3 months
obstructive valvular disease
exercise induced sustained arrhythmias or symptomatic myocardial ischemia
pregnancy
psychiatric disorder
non-compliance with medical regimen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389649

Locations


United States, Maryland
	University of Maryland
	Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

University of Maryland

American Heart Association

Investigators


Principal Investigator:	Stephen Gottlieb, MD	University of Maryland

More Information

Study ID Numbers:	H-20887
First Received:	October 17, 2006
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00389649
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Maryland:

congestive heart failure

pacemaker

heart rate

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 19, 2008