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Cardiac Resynchronization in the Elderly

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cardiac Resynchronization Therapy Pacemaker

Cardiac Resynchronization Therapy Defibrillator

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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)

Sites / Locations

Duke University Health System
The Ohio State University
UPMC Hamot
UPMC
Veterans Research Foundation of Pittsburgh
UPMC Pinnacle

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Randomized- Pacemaker (CRT-P)

Randomized- Defibrillator (CRT-D)

Observational- Pacemaker (CRT-P)

Observational- Defibrillator (CRT-D)

Arm Description

Cardiac resynchronization therapy Pacemaker

Cardiac resynchronization therapy Defibrillator

Cardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry

Cardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry

Outcomes

Primary Outcome Measures

Enrollment

Rates of enrollment of participants in this randomized trial

Secondary Outcome Measures

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.

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.

Retention

Rates of retention of participants in this randomized trial

Health Care Cost

Cost of health care between CRT-P and CRT-D recipients.

Full Information

NCT ID

NCT03031847

First Posted

January 19, 2017

Last Updated

July 27, 2022

Sponsor

Samir Saba

1. Study Identification

Unique Protocol Identification Number

NCT03031847

Brief Title

Cardiac Resynchronization in the Elderly

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

March 21, 2017 (Actual)

Primary Completion Date

August 18, 2021 (Actual)

Study Completion Date

August 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Samir Saba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Randomized- Pacemaker (CRT-P)

Arm Type

Other

Arm Description

Cardiac resynchronization therapy Pacemaker

Arm Title

Randomized- Defibrillator (CRT-D)

Arm Type

Other

Arm Description

Cardiac resynchronization therapy Defibrillator

Arm Title

Observational- Pacemaker (CRT-P)

Arm Type

Other

Arm Description

Cardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry

Arm Title

Observational- Defibrillator (CRT-D)

Arm Type

Other

Arm Description

Cardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry

Intervention Type

Device

Intervention Name(s)

Cardiac Resynchronization Therapy Pacemaker

Other Intervention Name(s)

CRT-P

Intervention Description

Patients randomized to the pacemaker arm will receive a CRT-P device.

Intervention Type

Device

Intervention Name(s)

Cardiac Resynchronization Therapy Defibrillator

Other Intervention Name(s)

CRT-D

Intervention Description

Patients randomized to the defibrillator arm will receive a CRT-D device.

Primary Outcome Measure Information:

Title

Enrollment

Description

Rates of enrollment of participants in this randomized trial

Time Frame

At 1 year after start of the study

Secondary Outcome Measure Information:

Title

QOL

Description

Time Frame

At 6 months after enrollment

Title

QOL2

Description

Time Frame

At 6 months after enrollment

Title

Retention

Description

Rates of retention of participants in this randomized trial

Time Frame

At 6 months after enrollment

Title

Health Care Cost

Description

Cost of health care between CRT-P and CRT-D recipients.

Time Frame

At 6 months after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samir Saba, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Health System

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

UPMC Hamot

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16550

Country

United States

Facility Name

UPMC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Veterans Research Foundation of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15240

Country

United States

Facility Name

UPMC Pinnacle

City

Wormleysburg

State/Province

Pennsylvania

ZIP/Postal Code

17043

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36350362

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.

Results Reference

derived

PubMed Identifier

35357219

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.

Results Reference

derived

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Cardiac Resynchronization in the Elderly

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