Trial Outcomes & Findings for Risk Stratification in Patients With Preserved Ejection Fraction (NCT NCT02124018)

Results Overview

The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD

Recruitment status

COMPLETED

Target enrollment

575 participants

Primary outcome timeframe

From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup

Results posted on

2019-09-04

Participant Flow

From April 2014 to July 2018, 575 consecutive patients were enrolled in the seven Departments of Cardiology participating in the study

Participant milestones

Participant milestones
Measure	Low Risk Group No Non-Invasive Risk Factors (NIRFs) present - no invasive programmed ventricular stimulation (PVS) performed	Intermediate Risk Group At least one NIRF present - noninducible upon programmed ventricular stimulation (PVS) (no sustained ventricular tachyarrhythmia was induced i.e. either with a duration \>30seconds or causing hemodynamic instability necessitating termination)	High Risk Group At least one NIRF present AND inducible upon PVS (sustained ventricular tachyarrhythmia was induced).
Overall Study STARTED	371	111	41
Overall Study COMPLETED	371	111	41
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Risk Group n=371 Participants No NIRFs present - no invasive PVS performed	Intermediate Risk Group n=111 Participants At least one NIRF present - noninducible upon PVS	High Risk Group n=41 Participants At least one NIRF present AND inducible upon PVS	Total n=523 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 10.2 • n=371 Participants	60 years STANDARD_DEVIATION 10.9 • n=111 Participants	61.7 years STANDARD_DEVIATION 9.2 • n=41 Participants	57 years STANDARD_DEVIATION 10.4 • n=523 Participants
Sex: Female, Male Female	57 Participants n=371 Participants	15 Participants n=111 Participants	1 Participants n=41 Participants	73 Participants n=523 Participants
Sex: Female, Male Male	314 Participants n=371 Participants	96 Participants n=111 Participants	40 Participants n=41 Participants	450 Participants n=523 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Greece	371 participants n=371 Participants	111 participants n=111 Participants	41 participants n=41 Participants	523 participants n=523 Participants

PRIMARY outcome

Timeframe: From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup

The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD

Outcome measures

Outcome measures
Measure	Low Risk Group n=371 Participants No NIRFs present - no invasive PVS performed	Intermediate Risk Group n=111 Participants At least one NIRF present - noninducible upon PVS	High Risk Group n=41 Participants At least one NIRF present AND inducible upon PVS.
Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation	0 participants	0 participants	9 participants

SECONDARY outcome

Timeframe: From completion of risk stratification to study completion or outcome occurrence (mean 32 months)

All-cause mortality

Outcome measures

Outcome measures
Measure	Low Risk Group n=371 Participants No NIRFs present - no invasive PVS performed	Intermediate Risk Group n=111 Participants At least one NIRF present - noninducible upon PVS	High Risk Group n=41 Participants At least one NIRF present AND inducible upon PVS.
Total Mortality	0 Participants	4 Participants	1 Participants

Adverse Events

Low Risk Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intermediate Risk Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

High Risk Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Konstantinos A. Gatzoulis

First Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens

Phone: 6944580369

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place