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Effect of Chronic Changes in Heart Rate on Congestive Heart Failure

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. Identifier: NCT00389649
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : December 23, 2019
American Heart Association
Information provided by (Responsible Party):
Steve Gottlieb, University of Maryland, Baltimore

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure, Congestive Device: heart rate setting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Chronic Changes in Heart Rate on Congestive Heart Failure
Study Start Date : November 2001
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. Ejection fraction, six minute walk, peak oxygen consumption

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00389649

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United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
American Heart Association
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Principal Investigator: Stephen Gottlieb, MD University of Maryland, College Park
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Responsible Party: Steve Gottlieb, Professor o Medicine, University of Maryland, Baltimore Identifier: NCT00389649    
Other Study ID Numbers: H-20887
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Keywords provided by Steve Gottlieb, University of Maryland, Baltimore:
congestive heart failure
heart rate
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases