An interventional study of Implantable Cardioverter Defibrillator and Optimal Medical Therapy in Cardiomyopathy, Coronary Artery Disease and Congestive Heart Failure, sponsored by VA Office of Research and Development. Terminated at 5 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death in patients 70 years and older. This study will assess the many competing factors involved with ICD implantation including 1) the impact on mortality, especially in the context of a declining rate of sudden death with advanced age, 2) the tolerability of the powerful therapeutic action of the device, and 3) the impact on quality of life.
The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death (SCD) in patients 70 years and older. In particular, this study is designed to determine the comparative effectiveness of ICD, in addition to optimal medical therapy (OMT), in reducing all-cause mortality, versus OMT alone; OMT includes standard intervention for chronic heart failure patients, i.e. lifestyle modification, disease management, adoption of healthy diet and exercise practices, etcetera. One particularly important secondary objective is to assess treatment efficacy under the conditions of high versus low co-morbidity burden.
Participants will be randomized (1:1 ratio) to ICD + OMT or OMT alone, and stratified by participating site and co-morbidity level (Charlson score \<3 versus 3+). Acute treatment visits will occur as clinically indicated and per local convention; follow-up will occur 1-4 months post-randomization (all participants), and not sooner than 30 days - and not later than 120 days post-implantation (ICD arm); regular follow-up will occur at 6 month intervals post-randomization until study close (all participants). All follow-up will be conducted centrally. Neither the participant nor treating clinician will be masked to treatment.
Primary Objective:
The primary objective of this study is to determine if a primary prevention strategy with ICD implantation in addition to optimal medical therapy (OMT) is effective in reducing all-cause mortality compared to OMT alone in patients 70 years of age and older who are eligible for ICD therapy according to current Centers for Medicare \& Medicaid Services (CMS) criteria.
Primary Hypothesis:
The primary hypothesis of this study is that implantation of an ICD plus optimal medical therapy will reduce all-cause mortality in patients 70 years of age and older versus optimal medical therapy alone.
Secondary Objectives:
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 167 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligible for ICD implementation according to the CMS criteria for primary prevention by one of the following conditions:
Exclusion Criteria:
ICD implantation in addition to Optimal Medical Therapy
Device: Implantable Cardioverter Defibrillator
Optimal Medical Therapy
Other: Optimal Medical Therapy
The ICD and lead(s) will be FDA-approved.
Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
Mortality
All-cause mortality
Time frame: Through study completion, starting from consent/baseline: average of 31 months.
Quality of Life - Minnesota Living With Heart Failure Questionnaire
Minnesota Living with Heart Failure questionnaire. MLHF scoring: 0 points = Best QOL, 105 points = Worst QOL.
Time frame: Measured at 12-months post-randomization
Sudden Cardiac Death
Sudden Cardiac Death
Time frame: Through study completion, starting from consent/baseline: average of 31 months.
All-cause Hospitalization
Number of participants hospitalized during study follow-up
Time frame: Through study completion, starting from consent/baseline: average of 31 months.
Recruitment at six Department of Veterans Affairs Medical Centers (VAMCs). Recruitment start: 8/6/2015 (4) 9/25/2015 (1) and 10/29/2015 (1). Recruitment terminated: 12/6/2016 (1) and 12/5/2019 (5).
| Milestone | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) |
|---|---|---|
| Started | 85 | 82 |
| Completed | 85 | 82 |
| Not completed | 0 | 0 |
All-cause mortality
| Participants | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) |
|---|---|---|
| Mortality | 23 | 20 |
Minnesota Living with Heart Failure questionnaire. MLHF scoring: 0 points = Best QOL, 105 points = Worst QOL.
| score on a scale | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) |
|---|---|---|
| Quality of Life - Minnesota Living With Heart Failure Questionnaire | 11 (6.0 to 26.5) | 13 (5.0 to 37.0) |
Sudden Cardiac Death
| Participants | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) |
|---|---|---|
| Sudden Cardiac Death | 5 | 3 |
Number of participants hospitalized during study follow-up
| Participants | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) |
|---|---|---|
| All-cause Hospitalization | 61 | 60 |
Collected over Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Optimal Medical Therapy | 23/85 (27.1%) | 67/85 (78.8%) | 1/85 (1.2%) |
| Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) | 20/82 (24.4%) | 62/82 (75.6%) | 6/82 (7.3%) |
| Event | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) |
|---|---|---|
| HF ComplicationCardiac disorders | 57/85 | 54/82 |
| Infection (other)Infections and infestations | 26/85 | 32/82 |
| Myocardial InfarctionCardiac disorders | 12/85 | 8/82 |
| Atrial fibrillation / Atrial flutterCardiac disorders | 9/85 | 2/82 |
| StrokeNervous system disorders | 2/85 | 3/82 |
| BleedingMetabolism and nutrition disorders | 0/85 | 1/82 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/85 | 1/82 |
| Infection (ICD)Infections and infestations | 1/85 | 0/82 |
| Lead AlterationProduct Issues | 1/85 | 0/82 |
| Event | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) |
|---|---|---|
| Painful implant siteGeneral disorders | 0/85 | 6/82 |
| New dizzinessNervous system disorders | 1/85 | 0/82 |
| Age, Categorical(Participants) | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 85 | 82 | 167 |
| Sex: Female, Male(Participants) | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 84 | 81 | 165 |
| Race (NIH/OMB)(Participants) | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 15 | 27 |
| White | 73 | 67 | 140 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) | Total |
|---|---|---|---|
| United States | 85 | 82 | 167 |
| New York Heart Association Class: I(Participants) | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) | Total |
|---|---|---|---|
| Count of participants | 2 | 4 | 6 |
| New York Heart Association Class: II(Participants) | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) | Total |
|---|---|---|---|
| Count of participants | 62 | 58 | 120 |
| New York Heart Association Class: III(Participants) | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) | Total |
|---|---|---|---|
| Count of participants | 21 | 20 | 41 |
| New York Heart Association Class: IV(Participants) | Optimal Medical Therapy | Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD) | Total |
|---|---|---|---|
| Count of participants | 0 | 0 | 0 |
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VA Office of Research and Development