CardiomyopathyI-70NCT02121158
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
A study testing Implantable Cardioverter Defibrillator and Optimal Medical Therapy in people with Cardiomyopathy and Coronary Artery Disease, run by VA Office of Research and Development at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cardiomyopathy, Coronary Artery Disease, Congestive Heart Failure
- What is being tested?
- Implantable Cardioverter Defibrillator and Optimal Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Aug 2015to 6 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422-0001
About this study
Official title: CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly
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.
Read the 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.
- Being tested
- Implantable Cardioverter Defibrillator, Optimal Medical Therapy
- Keywords
- CSP 592, ICD, cardiovascular, heart, aging, chronic diseases, multi-site trial, investigational device, cardiomyopathy, coronary artery disease, congestive heart failure, myocardial infarction, I-70, I70, elderly, defibrillator
- Medical subject headings
- Cardiomyopathies, Coronary Artery Disease, Heart Failure, Myocardial Infarction, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter DefibrillatorDevice
The ICD and lead(s) will be FDA-approved.
Optimal Medical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | ICD implantation in addition to Optimal Medical Therapy Receives: Device: Implantable Cardioverter Defibrillator |
| 2 | Active comparator | Optimal Medical Therapy Receives: Other: Optimal Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality
Measured: Through study completion, starting from consent/baseline: average of 31 months.
Secondary outcomes (3)
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.
Measured: Measured at 12-months post-randomization
Sudden Cardiac Death
Sudden Cardiac Death
Measured: Through study completion, starting from consent/baseline: average of 31 months.
All-cause Hospitalization
Number of participants hospitalized during study follow-up
Measured: Through study completion, starting from consent/baseline: average of 31 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study start7 Aug 2015
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Why it stopped: Results of the pilot were not enough to justify the extension of the pilot. Results presented are from pilot.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steve Singh, MD, Study chair, Washington DC VA Medical Center, Washington, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121158
- Sponsor's protocol ID
- 592
- Acronym
- I-70
- Status last verified
- Jul 2024
- First submitted
- 16 Apr 2014
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Singh SN, Wininger M, Raitt M, Adabag S, Moore H, Rottman JN, Scrymgeour A, Zhang J, Zheng K, Guarino P, Kyriakides TC; I-70 Study Group; Johnson G, Williams A, Beed A, MacMurdy K, Saavedra P. Efficacy and safety of implantable cardioverter-defibrillator implantation in the elderly-The I-70 Study: A randomized clinical trial. Heart Rhythm O2. 2024 Apr 27;5(6):365-373. doi: 10.1016/j.hroo.2024.04.010. eCollection 2024 Jun.
PubMed 38984364
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly
- ClinicalTrials.gov ID
- NCT02121158
- Acronym / sponsor ID
- I-70 / 592
- Keywords
- CSP 592, ICD, cardiovascular, heart, aging, chronic diseases, multi-site trial, investigational device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of the pilot were not enough to justify the extension of the pilot. Results presented are from pilot.
- Enrolment
- 167 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 7 Aug 2015 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 20 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Implantable Cardioverter DefibrillatorICD implantation in addition to Optimal Medical Therapy |
| 2 | Active comparator | Other: Optimal Medical TherapyOptimal Medical Therapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 70 years of age or older
- Eligible for ICD implementation according to the CMS criteria for primary prevention by one of the following conditions:
- Stable condition on Optimal Medical Therapy
- Able and willing to provide informed consent to participate in this study
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardioverter DefibrillatorThe ICD and lead(s) will be FDA-approved. | Device | 1 |
| Optimal Medical TherapyGuidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke. | Other | 2 |
Primary outcome
Mortality
Time frame: Through study completion, starting from consent/baseline: average of 31 months.
All-cause mortality
3 secondary outcomes
Quality of Life - Minnesota Living With Heart Failure Questionnaire
Time frame: Measured at 12-months post-randomization
Sudden Cardiac Death
Time frame: Through study completion, starting from consent/baseline: average of 31 months.
All-cause Hospitalization
Time frame: Through study completion, starting from consent/baseline: average of 31 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38984364Singh SN, Wininger M, Raitt M, Adabag S, Moore H, Rottman JN, Scrymgeour A, Zhang J, Zheng K, Guarino P, Kyriakides TC; I-70 Study Group; Johnson G, Williams A, Beed A, MacMurdy K, Saavedra P. Efficacy and safety of implantable cardioverter-defibrillator implantation in the elderly-The I-70 Study: A randomized clinical trial. Heart Rhythm O2. 2024 Apr 27;5(6):365-373. doi: 10.1016/j.hroo.2024.04.010. eCollection 2024 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Singh, MD study chair
Washington DC VA Medical Center, Washington, DC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Cardioverter Defibrillator and Optimal Medical Therapy in people with Cardiomyopathy and Coronary Artery Disease, run by VA Office of Research and Development at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Through study completion, starting from consent/baseline: average of 31 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.