Trial Outcomes & Findings for Endothelial Function and Cardiac Output in RV Pacing (NCT NCT00508196)

Last Updated: 2019-03-18

Results Overview

Flow mediated vasodilatation as measured by reactive hyperaemia peripheral arterial tonometry signal using EndoPAT software, Itamar. A post-occlusion to pre-occlusion ratio is calculated by the EndoPAT software, providing the EndoPAT index (EnFI)

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

1 week

Results posted on

2019-03-18

Participant Flow

Subjects previously implanted with a dual-chamber pacemaker for SND were recruited from the Ninewells Hospital and Medical School pacemaker clinic. No subject was pacemaker dependent and the indication for pacing was intermittent sinus arrest or sinus bradycardia.

Prior to randomization, as pre-study right ventricular pacing was variable among the subjects, pacing was programmed to produce minimal right ventricular pacing (using single-chamber atrial pacing or dual-chamber mode with long AV delay) for a minimal washout period of ≥1 week.

Participant milestones

Participant milestones
Measure	RVP-Max First, Then RVP-Min maximum RV pacing programmed (short AV delay) for 1 week, then at least 1 week washout, then minimum RV pacing (long AV delay)	RVP-Min First, Then RVP-Max Minimum RV pacing programmed (long AV delay) for 1 week, then at least 1 week washout, then maximum RV pacing (short AV delay)
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endothelial Function and Cardiac Output in RV Pacing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=22 Participants All subjects had the right ventricular lead implanted at the right ventricular apex. No subject was pacemaker dependent and the indication for pacing was intermittent sinus arrest or sinus bradycardia. Subjects with ongoing angina or heart failure symptoms, known AV node disease, bundle branch block, age \>80 years, atrial fibrillation, or inability to exercise, were excluded.
Age, Continuous	67.7 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Outcome measures

Outcome measures
Measure	RVP-min n=22 Participants Minimal RV pacing , with long AV delay programmed in DDD mode	RVP-Max n=22 Participants Maximum RV pacing with short AV delay programmed in DDD mode
Endothelial Function Assessed by Flow Mediated Vasodilatation	1.96 EndoPAT index (EnFI) Standard Deviation .37	1.73 EndoPAT index (EnFI) Standard Deviation 0.33

SECONDARY outcome

Timeframe: 1 week

Outcome measures

Outcome measures
Measure	RVP-min n=22 Participants Minimal RV pacing , with long AV delay programmed in DDD mode	RVP-Max n=22 Participants Maximum RV pacing with short AV delay programmed in DDD mode
B-type Natriuretic Pepetide	104.3 microgrammes /L Standard Deviation 108	112.8 microgrammes /L Standard Deviation 80.2

SECONDARY outcome

Timeframe: 1 week

measured at peak exercise on a standard exercise bicycle, measured non-invasively using the inert gas rebreathing technique (Innocor, Innovision A/S, Odense, Denmark).

Outcome measures

Outcome measures
Measure	RVP-min n=22 Participants Minimal RV pacing , with long AV delay programmed in DDD mode	RVP-Max n=22 Participants Maximum RV pacing with short AV delay programmed in DDD mode
Cardiac Output	7.65 L/min Standard Deviation 3.15	7.05 L/min Standard Deviation 2.61

Adverse Events

RVP-min

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RVP-Max

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

DR Anna Maria Choy

University of Dundee

Phone: 01382 383482

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place