Heart FailureNCT03031847
Cardiac Resynchronization in the Elderly
A study testing Cardiac Resynchronization Therapy Pacemaker and Cardiac Resynchronization Therapy Defibrillator in people with Heart Failure, run by Samir Saba at 6 sites in United States.
Trial summary
This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy Pacemaker and Cardiac Resynchronization Therapy Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Mar 2017to 18 Aug 2021
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age >/= 75 years
- Left Ventricular Ejection Fraction (LVEF) ≤ 35% by cardiac imaging including echocardiogram, nuclear imaging, cardiac catheterization, or cardiac magnetic resonance imaging
- QRS width >120 ms on surface electrocardiogram
- New York Heart Association class II, III, or ambulatory IV for Heart Failure (HF)
- Patient undergoing de novo CRT device implantation of CRT-D device change-out for battery depletion
Who cannot join
- Patient within 40 days of acute myocardial infarction
- Patient within 3 months of cardiac revascularization (percutaneous coronary intervention or bypass surgery)
- Patient with prior history of cardiac arrest or documented sustained ventricular arrhythmia
- Patient with expected longevity < 1 year
- Patient not on optimal medical therapy for HF management including when tolerated β-blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers
- Patient not planning to have his/her follow-up at participating institution
Show all 9Show fewer
- Patient unable or unwilling to sign a written informed consent
- Patient's with dementia that are unable to consent for themselves
- Participating in any other clinical trials (observational/registries allowed)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Ohio State University
Columbus, Ohio, 43210
Duke University Health System
Durham, North Carolina, 27710
UPMC Hamot
Erie, Pennsylvania, 16550
UPMC
Pittsburgh, Pennsylvania, 15213
Veterans Research Foundation of Pittsburgh
Pittsburgh, Pennsylvania, 15240
UPMC Pinnacle
Wormleysburg, Pennsylvania, 17043
About this study
Official title: Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)
This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be asked to enroll in a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.
Read the detailed description
The goal of this study is to pilot test a randomized, controlled, non-inferiority trial comparing the survival and quality of life (QOL) of older patients receiving cardiac resynchronization therapy (CRT) pacemaker (CRT-P) versus defibrillator (CRT-D) therapy. This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be enrolled and followed as part of a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy Pacemaker, Cardiac Resynchronization Therapy Defibrillator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy PacemakerDevice
Also called CRT-P
Patients randomized to the pacemaker arm will receive a CRT-P device.
Cardiac Resynchronization Therapy DefibrillatorDevice
Also called CRT-D
Patients randomized to the defibrillator arm will receive a CRT-D device.
| Study group | Role | What they receive |
|---|---|---|
| Randomized- Pacemaker (CRT-P) | Other | Cardiac resynchronization therapy Pacemaker Receives: Device: Cardiac Resynchronization Therapy Pacemaker |
| Randomized- Defibrillator (CRT-D) | Other | Cardiac resynchronization therapy Defibrillator Receives: Device: Cardiac Resynchronization Therapy Defibrillator |
| Observational- Pacemaker (CRT-P) | Other | Cardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry Receives: Device: Cardiac Resynchronization Therapy Pacemaker |
| Observational- Defibrillator (CRT-D) | Other | Cardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry Receives: Device: Cardiac Resynchronization Therapy Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Rates of enrollment of participants in this randomized trial
Measured: At 1 year after start of the study
Secondary outcomes (4)
QOL
Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires. The Minnesota Living with Heart Failure scale ranges from 0 to 105, in which a lower score indicates a better outcome. The Minnesota Living with Heart Failure Physical subscale ranges from 0 to 40 and the Minnesota Living with Heart Failure Mental subscale ranges from 0 to 25. Lower scores on the subscales indicate a better outcome.
Measured: At 6 months after enrollment
QOL2
QOL of CRT-P versus CRT-D recipients using RAND-36. The RAND-36 is a normalized scale with a range of 0 to 100, in which a higher score is indicative of a better outcome. PCS-T and MCS-T are the two summary components of the RAND-36. The subscales PCS-T and MCS-T are both normalized with a range of 0 to 100. Higher scores on the subscales indicate a better outcome.
Measured: At 6 months after enrollment
Retention
Rates of retention of participants in this randomized trial
Measured: At 6 months after enrollment
Health Care Cost
Cost of health care between CRT-P and CRT-D recipients.
Measured: At 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start21 Mar 2017
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
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 (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Model description
- Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samir Saba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samir Saba, University of Pittsburgh
- Investigators
- Samir Saba, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031847
- Sponsor's protocol ID
- PRO17010015
- Status last verified
- Dec 2023
- First submitted
- 19 Jan 2017
- Last updated
- 7 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dhande M, Myaskovsky L, Althouse A, Singh M, Weiss R, Shalaby A, Al-Khatib SM, Topoll A, Jain S, Saba S. Quality of Life and Type of Cardiac Resynchronization Therapy Device in Older Heart Failure Patients. J Palliat Med. 2023 Apr;26(4):481-488. doi: 10.1089/jpm.2022.0217. Epub 2022 Nov 8.
PubMed 36350362Althouse AD, Jain SK, Shalaby A, Singh M, Weiss R, Myaskovsky L, Al-Khatib SM, Saba S. Feasibility of a Randomized Clinical Trial of Cardiac Resynchronization Therapy With or Without an Implantable Defibrillator in Older Patients. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010795. doi: 10.1161/CIRCEP.121.010795. Epub 2022 Mar 31. No abstract available.
PubMed 35357219
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)
- ClinicalTrials.gov ID
- NCT03031847
- Acronym / sponsor ID
- PRO17010015
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Samir SabaUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Posted 23 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be asked to enroll in a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.
Detailed description
The goal of this study is to pilot test a randomized, controlled, non-inferiority trial comparing the survival and quality of life (QOL) of older patients receiving cardiac resynchronization therapy (CRT) pacemaker (CRT-P) versus defibrillator (CRT-D) therapy. This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P versus CRT-D and followed until study end. Rates of patient screening, enrollment, randomization, and retention as well as cost of care will be examined. The results of this pilot study will inform the design of a large pivotal non-inferiority trial and will be necessary for its success. Patients who refuse participation in the randomized pilot trial will be enrolled and followed as part of a prospective observational cohort. Characteristics of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their device decision will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)
| Arm | Type | Receives |
|---|---|---|
| Randomized- Pacemaker (CRT-P) | Other | Device: Cardiac Resynchronization Therapy PacemakerCardiac resynchronization therapy Pacemaker |
| Randomized- Defibrillator (CRT-D) | Other | Device: Cardiac Resynchronization Therapy DefibrillatorCardiac resynchronization therapy Defibrillator |
| Observational- Pacemaker (CRT-P) | Other | Device: Cardiac Resynchronization Therapy PacemakerCardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry |
| Observational- Defibrillator (CRT-D) | Other | Device: Cardiac Resynchronization Therapy DefibrillatorCardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age >/= 75 years
- Left Ventricular Ejection Fraction (LVEF) ≤ 35% by cardiac imaging including echocardiogram, nuclear imaging, cardiac catheterization, or cardiac magnetic resonance imaging
- QRS width >120 ms on surface electrocardiogram
- New York Heart Association class II, III, or ambulatory IV for Heart Failure (HF)
- Patient undergoing de novo CRT device implantation of CRT-D device change-out for battery depletion
Key exclusion criteria (9 listed)
- Patient within 40 days of acute myocardial infarction
- Patient within 3 months of cardiac revascularization (percutaneous coronary intervention or bypass surgery)
- Patient with prior history of cardiac arrest or documented sustained ventricular arrhythmia
- Patient with expected longevity < 1 year
- Patient not on optimal medical therapy for HF management including when tolerated β-blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers
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 |
|---|---|---|
| Cardiac Resynchronization Therapy PacemakerAlso: CRT-PPatients randomized to the pacemaker arm will receive a CRT-P device. | Device | Observational- Pacemaker (CRT-P), Randomized- Pacemaker (CRT-P) |
| Cardiac Resynchronization Therapy DefibrillatorAlso: CRT-DPatients randomized to the defibrillator arm will receive a CRT-D device. | Device | Observational- Defibrillator (CRT-D), Randomized- Defibrillator (CRT-D) |
Primary outcome
Enrollment
Time frame: At 1 year after start of the study
Rates of enrollment of participants in this randomized trial
4 secondary outcomes
QOL
Time frame: At 6 months after enrollment
QOL2
Time frame: At 6 months after enrollment
Retention
Time frame: At 6 months after enrollment
Health Care Cost
Time frame: At 6 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36350362Dhande M, Myaskovsky L, Althouse A, Singh M, Weiss R, Shalaby A, Al-Khatib SM, Topoll A, Jain S, Saba S. Quality of Life and Type of Cardiac Resynchronization Therapy Device in Older Heart Failure Patients. J Palliat Med. 2023 Apr;26(4):481-488. doi: 10.1089/jpm.2022.0217. Epub 2022 Nov 8.
- Derived from this study: PubMed 35357219Althouse AD, Jain SK, Shalaby A, Singh M, Weiss R, Myaskovsky L, Al-Khatib SM, Saba S. Feasibility of a Randomized Clinical Trial of Cardiac Resynchronization Therapy With or Without an Implantable Defibrillator in Older Patients. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010795. doi: 10.1161/CIRCEP.121.010795. Epub 2022 Mar 31. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
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.
Samir Saba, MD principal investigator
University of Pittsburgh
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy Pacemaker and Cardiac Resynchronization Therapy Defibrillator in people with Heart Failure, run by Samir Saba at 6 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 23 Aug 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?
Enrollment (time frame: At 1 year after start of the study). 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 NCT03031847, which also lists 2 linked publications.
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 7 Dec 2023.