CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
heart rate settingdevice
Likely dose
Not stated in record
Key inclusion· 3
  • Symptomatic congestive heart failure, NYHA Class II to IV
  • Ejection fraction <40% documented within 6 months
  • Stable on conventional therapy (digoxin, diuretics, ACE inhibitors, hydralazine, nitrates, ARBs, beta blockers) with no dosage changes for ≥4 weeks
Key exclusion· 7
  • Active alcohol or illicit drug use
  • Myocardial infarction or unstable angina within 3 months
  • Obstructive valvular disease
  • Exercise-induced sustained arrhythmias or symptomatic myocardial ischemia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00389649
NCT00389649N/ACompleted

Effect of Chronic Changes in Heart Rate on Congestive Heart Failure

University of Maryland, Baltimore·interventional·Posted Oct 19, 2006·Updated Dec 20, 2021

In Brief

A clinical study evaluating heart rate setting for Heart Failure, Congestive. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2006
Enrollment StartNov 1, 2001
Primary CompletionJun 1, 2005
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 19.7 years ago

Interventions

heart rate settingdevice