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Clinical Trials/NCT03232736
NCT03232736CompletedNot Applicable

Randomized interventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With mechaNical Circulatory Support Devices

University of Colorado, Denver1 site in 1 country22 target enrollmentStarted: October 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Peak Vo2

Study Overview

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Peak Vo2

Time Frame: 20 minutes

peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing

Cardiac Output

Time Frame: 20 minutes

cardiac output measured during invasive cardiopulmonary exercise testing.

Secondary Outcomes

  • Minute Ventilation(20 minutes)
  • Blood Pressure(20 minutes)
  • EES/EA(20 minutes)
  • Tau(20 minutes)
  • Stroke Work(20 minutes)
  • Respiratory Exchange Ratio(20 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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