Trial Outcomes & Findings for InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's (NCT NCT03232736)

NCT ID: NCT03232736

Last Updated: 2023-11-14

Results Overview

peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing

Recruitment status

COMPLETED

Target enrollment

22 participants

Primary outcome timeframe

20 minutes

Results posted on

2023-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Control healthy individuals free of cardiovascular disease and not on any cardiac-related medications, age \> 18years.	LVAD Group w/Pacemaker Pacemaker adjustments will be made to this group in blinded manner. Pacemaker adjustments: LVAD subjects with CRT device will have leads turned both on and off in blinded manner CRT: CRT device
Overall Study STARTED	9	13
Overall Study COMPLETED	9	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Control n=9 Participants Healthy controls free of heart disease and not on any medications. Age 18+ years	LVAD Group n=13 Participants Heart failure patients supported by LVAD	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 12 • n=5 Participants	61 years STANDARD_DEVIATION 9 • n=7 Participants	52 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 20 minutes

peak Vo2 measured by indirect calorimetry during cardiopulmonary exercise testing

Outcome measures

Outcome measures
Measure	Healthy Control n=9 Participants healthy people free of heart disease.	LVAD Group w/Pacemaker n=13 Participants heart failure patients supported by an LVD.
Peak Vo2	33 ml/kg/min Standard Deviation 10.4	12.5 ml/kg/min Standard Deviation 3.2

PRIMARY outcome

Timeframe: 20 minutes

cardiac output measured during invasive cardiopulmonary exercise testing.

Outcome measures

Outcome measures
Measure	Healthy Control n=9 Participants healthy people free of heart disease.	LVAD Group w/Pacemaker n=13 Participants heart failure patients supported by an LVD.
Cardiac Output	18.4 L/min Standard Deviation 7.3	9.1 L/min Standard Deviation 3.3

SECONDARY outcome

Timeframe: 20 minutes

mean arterial pressure during exercise

Outcome measures

Outcome measures
Measure	Healthy Control n=9 Participants healthy people free of heart disease.	LVAD Group w/Pacemaker n=13 Participants heart failure patients supported by an LVD.
Blood Pressure	119 mmHg Standard Deviation 7	91 mmHg Standard Deviation 10

SECONDARY outcome

Timeframe: 20 minutes

Respiratory exchange ratio derived from indirect calorimetry

Outcome measures

Outcome measures
Measure	Healthy Control n=9 Participants healthy people free of heart disease.	LVAD Group w/Pacemaker n=13 Participants heart failure patients supported by an LVD.
Respiratory Exchange Ratio	1.08 ratio Standard Deviation 0.08	0.03 ratio Standard Deviation 0.08

SECONDARY outcome

Timeframe: 20 minutes

Minute ventilation during cardiopulmonary exercise testing

Outcome measures

Outcome measures
Measure	Healthy Control n=9 Participants healthy people free of heart disease.	LVAD Group w/Pacemaker n=13 Participants heart failure patients supported by an LVD.
Minute Ventilation	102 L/min Standard Deviation 40	56 L/min Standard Deviation 19

SECONDARY outcome

Timeframe: 20 minutes

unit of measure of diastolic function during exercise

Outcome measures

Outcome measures
Measure	Healthy Control n=9 Participants healthy people free of heart disease.	LVAD Group w/Pacemaker n=13 Participants heart failure patients supported by an LVD.
Tau	25 msec Standard Deviation 6	54 msec Standard Deviation 49

SECONDARY outcome

Timeframe: 20 minutes

stroke work during exercise

Outcome measures

Outcome measures
Measure	Healthy Control n=9 Participants healthy people free of heart disease.	LVAD Group w/Pacemaker n=13 Participants heart failure patients supported by an LVD.
Stroke Work	4999 mmHg*mL Standard Deviation 2342	2455 mmHg*mL Standard Deviation 783

SECONDARY outcome

Timeframe: 20 minutes

ventricular arterial coupling during exercise

Outcome measures

Outcome measures
Measure	Healthy Control n=9 Participants healthy people free of heart disease.	LVAD Group w/Pacemaker n=13 Participants heart failure patients supported by an LVD.
EES/EA	1.6 ratio Standard Deviation 0.8	1.40 ratio Standard Deviation 0.34

Adverse Events

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LVAD Group w/Pacemaker

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Cornwell

University of Colorado Anschutz Medical Campus

Phone: 16142961686

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place