Personalised Risk scOre For Implantation of Defibrillators in Patients With Reduced LVEF≤35% and a Low Risk for Sudden Cardiac Death

NCT04540354 | Withdrawn DMC

• 2 other identifiers: LHI-2020-02847999
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to demonstrate that in post-MI patients with symptomatic heart failure who receive optimal medical therapy for this condition, and with reduced LVEF ≤ 35% but low risk for SCD according to a personalised risk score, optimal medical therapy without ICD implantation (index group) is not inferior to optimal medical therapy with ICD implantation (control group) with respect to all-cause mortality.

Conditions

Myocardial Infarction; Heart Failure; Sudden Cardiac Death

Keywords

Myocardial Infarction; Heart Failure; Sudden Cardiac Death; Implantable Cardioverter Defibrillator; PROFID; Personalized Medicine

Outcome Measures

Primary Outcomes (1)

• Time from randomisation to the occurrence of all-cause death

  Randomization to end of study (event-driven, expected about 15 months after last patient in)

Secondary Outcomes (5)

• Time from randomisation to death from cardivascular causes

  Randomization to end of study (event-driven, expected about 15 months after last patient in)

• Time from randomisation to sudden cardiac death

  Randomization to end of study (event-driven, expected about 15 months after last patient in)

• Time from randomisation to first hospital readmissions for cardiovascular causes after randomisation

  Randomization to end of study (event-driven, expected about 15 months after last patient in)

• Average length of stay in hospital during the study period

  Randomization to end of study (event-driven, expected about 15 months after last patient in)

• Quality of life (EQ-5D-5L) trajectories over time

  At baseline and 6-month intervals thereafter

Study Arms (2)

Optimal Medical Therapy without ICD device therapy

EXPERIMENTAL

Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure and will not receive an ICD device

Drug: Optimal Medical Therapy (OMT)

Optimal Medical Therapy with ICD device therapy

ACTIVE COMPARATOR

Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure and will receive an ICD device

Drug: Optimal Medical Therapy (OMT); Device: Implantable cardioverter-defibrillator (ICD)

Interventions

Optimal Medical Therapy (OMT) DRUG

Patients will be treated according to Optimal Medical Therapy defined by the 2016 ESC guidelines for the management of acute and chronic heart failure.

Optimal Medical Therapy with ICD device therapy; Optimal Medical Therapy without ICD device therapy

Implantable cardioverter-defibrillator (ICD) DEVICE

An ICD consists of an electronic medical device and electrode leads. The surgery can be performed in local anaesthesia, but a short general anaesthesia is required if the ICD has to be tested giving the patient an electric shock. Besides the possibility to shock during arrhythmias the ICD can potentially terminate ventricular tachycardias by rapid pacing for short periods (small bursts of pacing). The subcutaneous defibrillator is an established and valid alternative to the conventional ICD for the preven-tion of SCD. According to current guidelines, the subcutaneous defibrillator should be considered as an alternative to transvenous defibrillators in patients with an indication for an ICD when pacing therapy for bradycardia support, cardiac resynchronisation or antitachycardia pacing is not needed.

Optimal Medical Therapy with ICD device therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Documented history of myocardial infarction either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI).
• Symptomatic heart failure with NYHA class II or III.
• On Optimal Medical Therapy (OMT) for at least 3 months prior to enrolment.
• LVEF ≤ 35% at transthoracic echocardiography or cardiac magnetic resonance imaging (MRI).
• Predicted personalised annual risk of SCD according to the clinical risk calculator ≤2.5%.
• Signed informed consent.

You may not qualify if:

• Class I or IIa indication for implantation of an ICD for secondary prevention of sudden cardiac death and ventricular tachycardia (according to the 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death, see Appendix V).
• Ventricular tachycardia induced in an electrophysiologic study.
• Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
• Conclusive clinical indication for CRT (class I or IIa indication according to the 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure)
• Carrying any implanted cardiac pacemaker, defibrillator or CRT device.
• Violation of instruction for use (IFU) of the selected ICD device by at least one of the random group treatments.
• Hospitalised with unstable heart failure with NYHA class IV within 1 month prior to enrolment.
• Acute coronary syndrome or cardiac revascularization therapy by coronary angioplasty or coronary artery bypass grafting within 3 months prior to enrolment.
• Cardiac valve surgery or percutaneous cardiac valvular intervention such as transcatheter aortic valve replacement or transcatheter mitral valve repair performed within 3 months prior to enrolment.
• On the waiting list for heart transplantation.
• Any known disease that limits life expectancy to less than 1 year.
• Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in sub-studies connected to this trial is permitted).
• Previous participation in PROFID-Reduced.
• Drug abuse or clinically manifest alcohol abuse.

Sponsors & Collaborators

• Helios Health Institute GmbH: lead

Related Links

• Related Info

MeSH Terms

Conditions

Myocardial Infarction; Heart Failure; Death, Sudden, Cardiac

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Heart Arrest; Death, Sudden; Death

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Gerhard Hindricks, MD

  Department of Electrophysiology, Leipzig Heart Center at University of Leipzig

  PRINCIPAL INVESTIGATOR

• Nikolaos Dagres, MD

  Department of Electrophysiology, Leipzig Heart Center at University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The PROFID-Reduced trial is an open-label, blinded outcome assessment study. Thus, unblinding proce-dures for investigators are not applicable.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 7, 2020
• Study Start: February 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: March 8, 2023

Record last verified: 2020-09