InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's

Completed

• Conditions: Heart Diseases; Left Ventricular Dysfunction

• Registration Number: NCT03232736
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The primary reason the investigators are doing this study are to understand how the right side of the heart functions in heart failure patients with left ventricular assist devices (LVADs, or "mechanical hearts"). Second, the investigators are interested in understanding how different pacemaker settings influence function of the heart at rest and activity.

Detailed Description

Healthy individuals, as well as patients with advanced heart failure supported by LVADs, completed invasive hemodynamic analysis at rest and with exercise to characterize right-sided heart function at rest and with exercise during invasive cardiopulmonary exercise testing on upright cycle ergometry.

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-07-28
• Study Start: 2017-10-01
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Results First Submitted: 2021-06-18
• Results First Submitted QC: 2021-08-04
• Results First Posted: 2021-08-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Vo2	20 minutes	peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing
Cardiac Output	20 minutes	cardiac output measured during invasive cardiopulmonary exercise testing.

Secondary Outcome Measures

Name	Time	Method
EES/EA	20 minutes	ventricular arterial coupling during exercise
Tau	20 minutes	unit of measure of diastolic function during exercise
Minute Ventilation	20 minutes	Minute ventilation during cardiopulmonary exercise testing
Stroke Work	20 minutes	stroke work during exercise
Blood Pressure	20 minutes	mean arterial pressure during exercise
Respiratory Exchange Ratio	20 minutes	Respiratory exchange ratio derived from indirect calorimetry

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States