N/A N=13 Randomized Triple-blind Treatment

Effect of Chronic Changes in Heart Rate on Congestive Heart Failure

Heart Failure, Congestive

Bottom Line

View on ClinicalTrials.gov: NCT00389649 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcome: Primary: Ejection Fraction — 33; 30; 25 % of blood ejected with each beat

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: heart rate setting (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Jun 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Ejection Fraction	33; 30; 25	—
SECONDARY Peak Oxygen Consumption	11.0; 11.3; 9.5	—
SECONDARY Distance Traveled During a 6 Minute Walk	938; 996; 888	—

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00389649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.