Effect of Chronic Changes in Heart Rate on Congestive Heart Failure
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2001
Longer than P75 for not_applicable
1 active site
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
November 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 17, 2006
CompletedFirst Posted
Study publicly available on registry
October 19, 2006
CompletedResults Posted
Study results publicly available
December 20, 2021
CompletedDecember 20, 2021
November 1, 2021
3.6 years
October 17, 2006
October 16, 2021
November 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ejection Fraction
Ejection fraction as measured by nuclear ventriculography
2 months
Secondary Outcomes (2)
Peak Oxygen Consumption
2 months
Distance Traveled During a 6 Minute Walk
2 months
Study Arms (3)
HR=60
ACTIVE COMPARATORPacemaker set at 60
HR=75
ACTIVE COMPARATORPacemaker set at 75
HR=90
ACTIVE COMPARATORPacemaker set at 90
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Maryland, Baltimorelead
- American Heart Associationcollaborator
Study Sites (1)
University of Maryland
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephen Gottlieb, MD
- Organization
- Universitry of Maryland
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Gottlieb, MD
University of Maryland, College Park
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor o Medicine
Study Record Dates
First Submitted
October 17, 2006
First Posted
October 19, 2006
Study Start
November 1, 2001
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
December 20, 2021
Results First Posted
December 20, 2021
Record last verified: 2021-11