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NCT02124018: PRESERVE-EF

Risk Stratification in Patients With Preserved Ejection Fraction

Completed Results posted Last updated 4 September 2019
What this trial tests

trial testing Programmed ventricular stimulation in Myocardial Infarction in 575 participants. Completed in 31 July 2018.

Timeline
1 April 2014
Primary endpoint
31 July 2018
31 July 2018

Quick facts

Lead sponsorUniversity of Athens
StatusCompleted
Study typeOBSERVATIONAL
Enrollment575
Start date1 April 2014
Primary completion31 July 2018
Estimated completion31 July 2018
Sites1 location across Greece

Drugs / interventions tested

Conditions studied

Sponsor

University of Athens

Who can join

Adults 18 to 80, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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

GroupValue95% CI
Low Risk Group0
Intermediate Risk Group0
High Risk Group9
Total Mortality Secondary · From completion of risk stratification to study completion or outcome occurrence (mean 32 months)

All-cause mortality

GroupValue95% CI
Low Risk Group0
Intermediate Risk Group4
High Risk Group1

Sponsor's own description

The purpose of the study is to assess the prevalence and the prognostic value of non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF)\>40%.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: the PRESERVE EF study.
    Gatzoulis KA, Tsiachris D, Arsenos P, Antoniou CK, et al · · 2019 · cited 93× · PMID 31049557 · DOI 10.1093/eurheartj/ehz260
  2. Prediction of heart failure patients with distinct left ventricular ejection fraction levels using circadian ECG features and machine learning.
    Al Younis SM, Hadjileontiadis LJ, Khandoker AH, Stefanini C, et al · · 2024 · cited 9× · PMID 38739639 · DOI 10.1371/journal.pone.0302639
  3. Temporal changes of noninvasive electrocardiographic risk factors for sudden cardiac death in post-myocardial infarction patients with preserved ejection fraction: Insights from the PRESERVE-EF study.
    Xenogiannis I, Gatzoulis KA, Flevari P, Ikonomidis I, et al · · 2020 · cited 8× · PMID 31605453 · DOI 10.1111/anec.12701
  4. Investigating automated regression models for estimating left ventricular ejection fraction levels in heart failure patients using circadian ECG features.
    Al Younis SM, Hadjileontiadis LJ, Al Shehhi AM, Stefanini C, et al · · 2023 · cited 6× · PMID 38079417 · DOI 10.1371/journal.pone.0295653

Verify or expand the search:

Other trials of Programmed ventricular stimulation

Trials testing the same drug.

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

Other University of Athens trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02124018.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing