Clinical trial NCT03031847: Cardiac Resynchronization in the Elderly
Official title: Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 102
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Age \>/= 75 years
2. Left Ventricular Ejection Fraction (LVEF) ≤ 35% by cardiac imaging including echocardiogram, nuclear imaging, cardiac catheterization, or cardiac magnetic resonance imaging
3. QRS width \>120 ms on surface electrocardiogram
4. New York Heart Association class II, III, or ambulatory IV for Heart Failure (HF)
5. Patient undergoing de novo CRT device implantation of CRT-D device change-out for battery depletion

Exclusion Criteria:

1. Patient within 40 days of acute myocardial infarction
2. Patient within 3 months of cardiac revascularization (percutaneous coronary intervention or bypass surgery)
3. Patient with prior history of cardiac arrest or documented sustained ventricular arrhythmia
4. Patient with expected longevity \< 1 year
5. Patient not on optimal medical therapy for HF management including when tolerated β-blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers
6. Patient not planning to have his/her follow-up at participating institution
7. Patient unable or unwilling to sign a written informed consent
8. Patient's with dementia that are unable to consent for themselves
9. Participating in any other clinical trials (observational/registries allowed)

Primary outcomes:
measure: Enrollment
timeFrame: At 1 year after start of the study
Secondary outcomes:
measure: QOL
timeFrame: At 6 months after enrollment
measure: QOL2
timeFrame: At 6 months after enrollment
measure: Retention
timeFrame: At 6 months after enrollment
measure: Health Care Cost
timeFrame: At 6 months after enrollment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Veterans Research Foundation of Pittsburgh
state: Pennsylvania
city: Wormleysburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Samir Saba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Althouse 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.