- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02121158
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly (I-70)
CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly
Study Overview
Status
Intervention / Treatment
Detailed Description
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:
- One secondary objective of this study is to ascertain whether age, co-morbidity burden, or age and burden together, are determinants in mortality outcomes in the OMT versus ICD + OMT group.
- An additional secondary objective of the study is to determine the effect of ICD implantation plus optimal medical therapy on quality of life among elderly patients compared with optimal medical therapy alone.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20422
- Washington DC VA Medical Center, Washington, DC
-
-
Florida
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Gainesville, Florida, United States, 32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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-
Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
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-
Oregon
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Portland, Oregon, United States, 97239
- VA Portland Health Care System, Portland, OR
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Tennessee
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Nashville, Tennessee, United States, 37212-2637
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 70 years of age or older
Eligible for ICD implementation according to the CMS criteria for primary prevention by one of the following conditions:
- Documented prior MI and a measured left ventricular ejection fraction (LVEF) <=30% (includes New York Heart Association [NYHA] class I, II, or III)
- Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction <=35%, and inducible, sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) at electrophysiology (EP) study
- Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA class II and III heart failure, and measured LVEF <=35%
- Non-ischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart failure, and measured LVEF <=35%
- Stable condition on Optimal Medical Therapy
- Able and willing to provide informed consent to participate in this study
Exclusion Criteria:
- Enrolled in or planning to enroll in a conflicting trial
- Receiving a bi-ventricular ICD device
- New York Heart Association class IV heart failure
- Cardiogenic shock or symptomatic hypotension while in stable baseline rhythm,
- Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months
- An MI within the past 40 days
- Clinical symptoms or findings that would make them a candidate for coronary revascularization
- Irreversible brain damage from pre-existing cerebral disease
- Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year
- Circumstance that would prevent completion of the trial and follow-up activities, including medical condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
ICD implantation in addition to Optimal Medical Therapy
|
The ICD and lead(s) will be FDA-approved.
|
Active Comparator: 2
Optimal Medical Therapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: Through study completion, starting from consent/baseline: average of 31 months.
|
All-cause mortality
|
Through study completion, starting from consent/baseline: average of 31 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life - Minnesota Living With Heart Failure Questionnaire
Time Frame: Measured at 12-months post-randomization
|
Minnesota Living with Heart Failure questionnaire.
MLHF scoring: 0 points = Best QOL, 105 points = Worst QOL.
|
Measured at 12-months post-randomization
|
Sudden Cardiac Death
Time Frame: Through study completion, starting from consent/baseline: average of 31 months.
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Sudden Cardiac Death
|
Through study completion, starting from consent/baseline: average of 31 months.
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All-cause Hospitalization
Time Frame: Through study completion, starting from consent/baseline: average of 31 months.
|
Number of participants hospitalized during study follow-up
|
Through study completion, starting from consent/baseline: average of 31 months.
|
Collaborators and Investigators
Investigators
- Study Chair: Steve Singh, MD, Washington DC VA Medical Center, Washington, DC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 592
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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