Cardiac Resynchronization in the Elderly

Heart Failure Clinical Trial

Official title:

Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031847
• Other study ID #: PRO17010015
• Status: Completed
• Phase: N/A
• Start date: March 21, 2017
• Est. completion date: August 18, 2021

Study information

• Verified date: December 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 18, 2021
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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 ß-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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Cardiac Resynchronization Therapy Pacemaker
Patients randomized to the pacemaker arm will receive a CRT-P device.
• Cardiac Resynchronization Therapy Defibrillator
Patients randomized to the defibrillator arm will receive a CRT-D device.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	Duke University Health System	Durham	North Carolina
United States	UPMC Hamot	Erie	Pennsylvania
United States	UPMC	Pittsburgh	Pennsylvania
United States	Veterans Research Foundation of Pittsburgh	Pittsburgh	Pennsylvania
United States	UPMC Pinnacle	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Samir Saba

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	Rates of enrollment of participants in this randomized trial	At 1 year after start of the study
Secondary	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.	At 6 months after enrollment
Secondary	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.	At 6 months after enrollment
Secondary	Retention	Rates of retention of participants in this randomized trial	At 6 months after enrollment
Secondary	Health Care Cost	Cost of health care between CRT-P and CRT-D recipients.	At 6 months after enrollment