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Effect of Chronic Changes in Heart Rate on Congestive Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389649
First Posted: October 19, 2006
Last Update Posted: April 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Heart Association
Information provided by:
University of Maryland
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Chronic Changes in Heart Rate on Congestive Heart Failure

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00389649     History of Changes
Other Study ID Numbers: H-20887
First Submitted: October 17, 2006
First Posted: October 19, 2006
Last Update Posted: April 17, 2008
Last Verified: April 2008

Keywords provided by University of Maryland:
congestive heart failure
pacemaker
heart rate

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases