ICD for Heart Failure

(CONTEMP-ICD Trial)

Overseen By Ilan Goldenberg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3.5 years

3290 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator (ICD) vs. ICD management in patients with heart failure with reduced ejection fraction (HFrEF).

Research Team

Ilan Goldenberg, MD

Principal Investigator

Univ of Rochester Medical Center, Clinical Cardiovascular Research Center

Eligibility Criteria

This trial is for adults with heart failure who are on a comprehensive treatment plan including beta-blockers and other specific medications, or have a high enough score on the GDMT scale. They must also meet certain criteria based on their heart function (LVEF percentage) and symptoms. People with less severe conditions or those not meeting the medication requirements cannot participate.

Inclusion Criteria

I am on four specific heart failure medications or my treatment score is 6 or higher.

My MADIT-ICD Benefit Score is below 50.

I am 18 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either ICD implantation or no ICD implantation and receive guideline-directed medical therapy

3.5 years

Visits at initial, 3 months, 6 months, and every 6 months thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment, including all-cause mortality and major adverse cardiovascular events

3.5 years

Treatment Details

Interventions

• ICD

Trial Overview The study aims to compare two approaches in patients with reduced heart function due to heart failure: one group will receive an implantable cardioverter defibrillator (ICD), while the other will not. The main goal is to see if there's a difference in survival rates between the two groups.

Participant Groups

Group I: No-ICD implantation Active Control 1 Intervention

No-ICD implantation despite current recommendation

Group II: ICD implantation Active Control 1 Intervention

ICD implantation based on current guidelines

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+