ICD for Heart Failure

(CONTEMP-ICD Trial)

Recruiting at 12 trial locations

Overseen By Ilan Goldenberg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Beta-blockers, ARNI/ARB/ACE, MRA, SGLT2i

Disqualifiers: Existing ICD/CRT-D, Chronic renal failure, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an implantable cardioverter defibrillator (ICD), a device that helps prevent sudden heart problems, can lower the risk of death in people with heart failure with reduced ejection fraction (HFrEF). Researchers will compare two groups: one receiving the ICD and the other not, despite current guidelines recommending it. Ideal participants are adults with heart failure who have had stable treatment for at least a month and meet specific heart function criteria. As an unphased trial, this study offers participants the chance to contribute to important research that could influence future heart failure treatments.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should be stable on their current heart failure medications for at least one month before joining the study.

What prior data suggests that ICD management is safe for heart failure patients?

A previous study showed that implantable cardioverter defibrillators (ICDs) reduce the risk of death by 24% in patients with heart failure, effectively lowering the chance of dying. ICDs are devices that help maintain a normal heart rhythm.

Research has shown that most patients tolerate ICDs well. While some side effects can occur, serious problems are rare. For most, the benefits of preventing sudden heart-related death outweigh the risks.

For questions about what to expect, consulting a healthcare provider is advisable. They can provide more details about how ICDs work and what to monitor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ICD (implantable cardioverter-defibrillator) for heart failure because it offers a preventive approach to managing sudden cardiac death, which is a significant risk for heart failure patients. Unlike medications that manage symptoms or lifestyle changes that reduce risk factors, ICDs actively monitor heart rhythms and can deliver a shock to restore normal rhythm if a dangerous arrhythmia is detected. This proactive intervention could mean a life-saving difference for patients, offering peace of mind and potentially improving survival rates.

What evidence suggests that ICD implantation is effective for heart failure?

Studies have shown that implantable cardioverter-defibrillators (ICDs) can benefit patients with heart failure with reduced ejection fraction (HFrEF). These devices prevent sudden cardiac death, a risk for some with heart failure. Research indicates that patients with ICDs often live longer than those without them. This trial will compare two groups: one receiving ICD implantation based on current guidelines and another without ICD implantation despite current recommendations. The benefit appears in patients with heart conditions caused by blocked blood flow (ischemic) and those not related to blocked blood flow (non-ischemic). Overall, ICDs are generally considered helpful for managing heart failure in certain patients. ^{1 5 6 7 8}

Who Is on the Research Team?

Ilan Goldenberg, MD

Principal Investigator

Univ of Rochester Medical Center, Clinical Cardiovascular Research Center

Are You a Good Fit for This Trial?

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 need a device to prevent heart rhythm problems due to weak heart muscles.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5828273/

Long‐term outcomes of heart failure patients who received ... Implantable cardioverter‐defibrillator (ICD) therapy is indicated for selected heart failure patients for the primary prevention of sudden cardiac death.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X25005298

Contemporary Implantable Cardioverter-Defibrillator Benefit Guideline-directed device therapies in heart failure: a clinical practice-based analysis using electronic health record data. Am Heart J Plus, ...

3. nature.com nature.com/articles/s41598-025-09074-z

Comparative analysis of implantable cardioverter ... ... defibrillator efficacy in ischemic and non-ischemic cardiomyopathy in patients with heart failure ... outcomes with empagliflozin in heart ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2020.05.061

Long-Term Outcomes of Implantable Cardioverter ... TRANSLATIONAL OUTLOOK: The long-term benefit of ICD therapy appears to vary in relation to the etiology of heart failure, and further research ...

5. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03761-w

Impact of implantable cardioverter defibrillators on mortality in ... 2 (hypertensive heart and chronic kidney disease with congestive HF and renal failure), and I42.0 (dilated cardiomyopathy). Comorbidities were ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5461475/

Implantable cardioverter defibrillators for primary prevention of ... ICDs reduce mortality by 24% in both patients with (P = 0.03) and without IHD (P = 0.0023). When deciding on ICD therapy, classification of heart failure by ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.124.013479

Global and Temporal Trends in Utilization and Outcomes of ... Implantable cardioverter defibrillator (ICD) plays a major role in mitigation of sudden cardiac death risk in hypertrophic cardiomyopathy. •.

8. jacc.org jacc.org/doi/10.1016/j.jacc.2024.11.023

ACC/AHA/ASE/HFSA/HRS/SCAI/SCCT/SCMR 2025 ... Predicting survival in patients with heart failure with an implantable cardioverter defibrillator: The Heart Failure Meta-Score. J Card Fail. 2018;24:735 ...