Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly (I-70)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02121158
First received: April 16, 2014
Last updated: March 4, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Cardiomyopathy
Coronary Artery Disease
Congestive Heart Failure
Myocardial Infarction
Device: Implantable Cardioverter Defibrillator
Other: Optimal Medical Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 who are eligible for ICD therapy according to current Centers for Medicare & Medicaid Services (CMS) criteria.


Estimated Enrollment: 100
Study Start Date: August 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
ICD implantation in addition to optimal medical therapy
Device: Implantable Cardioverter Defibrillator
The ICD and lead(s) will be FDA-approved.
Active Comparator: 2
Optimal Medical Therapy
Other: 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.

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:

  1. 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.
  2. 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.
  Eligibility

Ages Eligible for Study:   70 Years and older   (Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 70 years of age or older
  2. Eligible for ICD implementation according to the CMS criteria for primary prevention by one of the following conditions:

    1. Documented prior MI and a measured left ventricular ejection fraction (LVEF) <=30% (includes New York Heart Association [NYHA] class I, II, or III)
    2. 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
    3. Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA class II and III heart failure, and measured LVEF <=35%
    4. Non-ischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III heart failure, and measured LVEF <=35%
  3. Stable condition on Optimal Medical Therapy
  4. Able and willing to provide informed consent to participate in this study

Exclusion Criteria:

  1. Enrolled in or planning to enroll in a conflicting trial
  2. Receiving a bi-ventricular ICD device
  3. New York Heart Association class IV heart failure
  4. Cardiogenic shock or symptomatic hypotension while in stable baseline rhythm,
  5. Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months
  6. An MI within the past 40 days
  7. Clinical symptoms or findings that would make them a candidate for coronary revascularization
  8. Irreversible brain damage from pre-existing cerebral disease
  9. Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year
  10. Circumstance that would prevent completion of the trial and follow-up activities, including medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02121158

Contacts
Contact: Michael Wininger, PhD (203) 932-5711 ext 3262 michael.wininger@va.gov
Contact: Jane Zhang, PhD (203) 932-5711 ext 3779 jane.zhang@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Minang (Mintu) Turakhia, MD    650-493-5000 ext 6689    minang.turakhia@va.gov   
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC Recruiting
Washington, District of Columbia, United States, 20422
Contact: Steve Singh, MD    202-745-8115    steve.singh@va.gov   
Contact: Suzanne McNicholas    (202) 745-5223    suzanne.mcnicholas@va.gov   
Study Chair: Steve Singh, MD         
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: Matthew McKillop, MD    352-376-1611 ext 4457    matthew.mckillop@va.gov   
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Selcuk Adabag, MD    612-467-3655    selcuk.adabag@va.gov   
United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Karen MacMurdy, MD    503-220-8262    karen.macmurdy@va.gov   
United States, Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Recruiting
Nashville, Tennessee, United States, 37212-2637
Contact: Pablo Saavedra, MD    615-873-6940    pablo.saavedra@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Study Chair: Steve Singh, MD Washington DC VA Medical Center, Washington, DC
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02121158     History of Changes
Other Study ID Numbers: 592 
Study First Received: April 16, 2014
Last Updated: March 4, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
CSP 592
ICD
cardiovascular
heart
aging
chronic diseases
multi-site trial
phase 3
investigational device
cardiomyopathy
coronary artery disease
congestive heart failure
myocardial infarction
I-70
I70
elderly
defibrillator

Additional relevant MeSH terms:
Heart Failure
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 21, 2016