Cardiac Resynchronization in the Elderly

• Sponsor: Samir Saba (Other)
• Overall Status: Completed
• CT.gov ID: NCT03031847
• Collaborator: (none)
• Enrollment: 102
• Locations: 6
• Arms: 4
• Actual Duration (Months): 52.9
• Patients Per Site: 17
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Cardiac Resynchronization Therapy Pacemaker; Device: Cardiac Resynchronization Therapy Defibrillator	N/A

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

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)
• Actual Study Start Date: Mar 21, 2017
• Actual Primary Completion Date: Aug 18, 2021
• Actual Study Completion Date: Aug 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Randomized- Pacemaker (CRT-P) Cardiac resynchronization therapy Pacemaker	Device: Cardiac Resynchronization Therapy Pacemaker; Patients randomized to the pacemaker arm will receive a CRT-P device.; Other Names: CRT-P
Other: Randomized- Defibrillator (CRT-D) Cardiac resynchronization therapy Defibrillator	Device: Cardiac Resynchronization Therapy Defibrillator; Patients randomized to the defibrillator arm will receive a CRT-D device.; Other Names: CRT-D
Other: Observational- Pacemaker (CRT-P) Cardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry	Device: Cardiac Resynchronization Therapy Pacemaker; Patients randomized to the pacemaker arm will receive a CRT-P device.; Other Names: CRT-P
Other: Observational- Defibrillator (CRT-D) Cardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry	Device: Cardiac Resynchronization Therapy Defibrillator; Patients randomized to the defibrillator arm will receive a CRT-D device.; Other Names: CRT-D

Outcome Measures

Primary Outcome Measures

1. Enrollment [At 1 year after start of the study]

   Rates of enrollment of participants in this randomized trial

Secondary Outcome Measures

1. QOL [At 6 months after enrollment]

   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.

2. QOL2 [At 6 months after enrollment]

   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.

3. Retention [At 6 months after enrollment]

   Rates of retention of participants in this randomized trial

4. Health Care Cost [At 6 months after enrollment]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 75 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Health System	Durham	North Carolina	United States	27710
2	The Ohio State University	Columbus	Ohio	United States	43210
3	UPMC Hamot	Erie	Pennsylvania	United States	16550
4	UPMC	Pittsburgh	Pennsylvania	United States	15213
5	Veterans Research Foundation of Pittsburgh	Pittsburgh	Pennsylvania	United States	15240
6	UPMC Pinnacle	Wormleysburg	Pennsylvania	United States	17043

Sponsors and Collaborators

• Samir Saba

Investigators

• Principal Investigator: Samir Saba, MD, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 24, 2018

More Information

Publications

None provided.

• Responsible Party: Samir Saba, Associate Professor <Me; Associate Chief of Cardiology; Director of Cardiovascular Electrophysiology;, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03031847
• Other Study ID Numbers: PRO17010015
• First Posted: Jan 26, 2017
• Last Update Posted: Aug 23, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	Randomized- Pacemaker (CRT-P)	Randomized- Defibrillator (CRT-D)	Observational- Pacemaker (CRT-P)	Observational- Defibrillator (CRT-D)
Arm/Group Description	Patients assigned to the pacemaker arm will receive CRT-P device	Patients assigned to the defibrillator arm will receive CRT-D device	Patients in observational arm that chose CRT-P device	Patients in observational arm that chose CRT-D device
Period Title: Overall Study
STARTED	22	20	18	42
COMPLETED	20	18	14	36
NOT COMPLETED	2	2	4	6

Baseline Characteristics

Arm/Group Title	Randomized- Pacemaker (CRT-P)	Randomized- Defibrillator (CRT-D)	Observational- Pacemaker (CRT-P)	Observational- Defibrillator (CRT-D)	Total
Arm/Group Description	Patients assigned to the pacemaker arm will receive CRT-P device	Patients assigned to the defibrillator arm will receive CRT-D device	Patients in observational arm that chose CRT-P device	Patients in observational arm that chose CRT-D device	Total of all reporting groups
Overall Participants	22	20	18	42	102
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	22 100%	20 100%	18 100%	42 100%	102 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	80.7 (4.3)	81.4 (4.9)	84.7 (4.6)	80.6 (4.0)	81.5 (4.5)
Sex: Female, Male (Count of Participants)
Female	7 31.8%	7 35%	6 33.3%	8 19%	28 27.5%
Male	15 68.2%	13 65%	12 66.7%	34 81%	74 72.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.5%	0 0%	0 0%	0 0%	1 1%
Not Hispanic or Latino	21 95.5%	20 100%	18 100%	42 100%	101 99%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	1 4.5%	1 5%	0 0%	3 7.1%	5 4.9%
White	20 90.9%	18 90%	18 100%	38 90.5%	94 92.2%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 4.5%	1 5%	0 0%	1 2.4%	3 2.9%
Region of Enrollment (participants) [Number]
United States	22 100%	20 100%	18 100%	42 100%	102 100%

Outcome Measures

1. Primary Outcome

Title	Enrollment
Description	Rates of enrollment of participants in this randomized trial
Time Frame	At 1 year after start of the study

Outcome Measure Data

Analysis Population Description

Participants Enrolled

Arm/Group Title	Randomized- Pacemaker (CRT-P)	Randomized- Defibrillator (CRT-D)	Observational- Pacemaker (CRT-P)	Observational- Defibrillator (CRT-D)
Arm/Group Description	Patients assigned to the pacemaker arm will receive CRT-P device	Patients assigned to the defibrillator arm will receive CRT-D device	Patients in observational arm that chose CRT-P device	Patients in observational arm that chose CRT-D device
Measure Participants	22	20	18	42
Count of Participants [Participants]	22 100%	20 100%	18 100%	42 100%

2. Secondary Outcome

Title	QOL
Description	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.
Time Frame	At 6 months after enrollment

Outcome Measure Data

Analysis Population Description

Only participants with complete 6-month data for QoL assessments were reported.

Arm/Group Title	Randomized- Pacemaker (CRT-P)	Randomized- Defibrillator (CRT-D)	Observational- Pacemaker (CRT-P)	Observational- Defibrillator (CRT-D)
Arm/Group Description	Patients assigned to the pacemaker arm will receive CRT-P device	Patients assigned to the defibrillator arm will receive CRT-D device	Patients in observational arm that chose CRT-P device	Patients in observational arm that chose CRT-D device
Measure Participants	17	17	12	32
Overall QOL: MLWHF Questionnaire	31.5 (30.3)	16.1 (19.6)	18.4 (9.6)	37.8 (24.3)
Physical QOL	14.1 (13.8)	8.2 (9.4)	10.7 (7.7)	18.9 (11.2)
Emotional QOL	7.0 (7.9)	3.5 (5.4)	2.9 (2.8)	7.5 (7.0)

3. Secondary Outcome

Title	QOL2
Description	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.
Time Frame	At 6 months after enrollment

Outcome Measure Data

Analysis Population Description

Only participants with complete 6-month data for QoL assessments were reported.

Arm/Group Title	Randomized- Pacemaker (CRT-P)	Randomized- Defibrillator (CRT-D)	Observational- Pacemaker (CRT-P)	Observational- Defibrillator (CRT-D)
Arm/Group Description	Patients assigned to the pacemaker arm will receive CRT-P device	Patients assigned to the defibrillator arm will receive CRT-D device	Patients in observational arm that chose CRT-P device	Patients in observational arm that chose CRT-D device
Measure Participants	17	17	12	32
Rand-36: PCS-T	37.4 (14.5)	45.0 (12.4)	37.7 (10.5)	35.0 (11.2)
Rand-36: MCS-T	49.0 (13.4)	51.4 (10.4)	51.6 (10.4)	47.7 (13.7)

4. Secondary Outcome

Title	Retention
Description	Rates of retention of participants in this randomized trial
Time Frame	At 6 months after enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Randomized- Pacemaker (CRT-P)	Randomized- Defibrillator (CRT-D)	Observational- Pacemaker (CRT-P)	Observational- Defibrillator (CRT-D)
Arm/Group Description	Patients assigned to the pacemaker arm will receive CRT-P device	Patients assigned to the defibrillator arm will receive CRT-D device	Patients in observational arm that chose CRT-P device	Patients in observational arm that chose CRT-D device
Measure Participants	22	20	18	42
Count of Participants [Participants]	17 77.3%	17 85%	12 66.7%	32 76.2%

5. Secondary Outcome

Title	Health Care Cost
Description	Cost of health care between CRT-P and CRT-D recipients.
Time Frame	At 6 months after enrollment

Outcome Measure Data

Analysis Population Description

Data was not collected

Arm/Group Title	Randomized- Pacemaker (CRT-P)	Randomized- Defibrillator (CRT-D)	Observational- Pacemaker (CRT-P)	Observational- Defibrillator (CRT-D)
Arm/Group Description	Patients assigned to the pacemaker arm will receive CRT-P device	Patients assigned to the defibrillator arm will receive CRT-D device	Patients in observational arm that chose CRT-P device	Patients in observational arm that chose CRT-D device
Measure Participants	0	0	0	0

Adverse Events

Time Frame	Up to 24 months.
Adverse Event Reporting Description	Adverse events were collected and classified as serious or not serious, cardiac or not cardiac. Cardiac events were further differentiated by arrhythmic or non-arrhythmic. Adverse events were not classified by specific organ system.
Arm/Group Title	Randomized- Pacemaker (CRT-P)		Randomized- Defibrillator (CRT-D)		Observational- Pacemaker (CRT-P)		Observational- Defibrillator (CRT-D)
Arm/Group Description	Patients assigned to the pacemaker arm will receive CRT-P device.		Patients assigned to the defibrillator arm will receive CRT-D device		Patients in observational arm that chose CRT-P device		Patients in observational arm that chose CRT-D device
All Cause Mortality
	Randomized- Pacemaker (CRT-P)		Randomized- Defibrillator (CRT-D)		Observational- Pacemaker (CRT-P)		Observational- Defibrillator (CRT-D)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/22 (13.6%)		3/20 (15%)		6/18 (33.3%)		17/42 (40.5%)
Serious Adverse Events
	Randomized- Pacemaker (CRT-P)		Randomized- Defibrillator (CRT-D)		Observational- Pacemaker (CRT-P)		Observational- Defibrillator (CRT-D)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/22 (27.3%)		3/20 (15%)		9/18 (50%)		18/42 (42.9%)
Cardiac disorders
Cardiac	2/22 (9.1%)		1/20 (5%)		4/18 (22.2%)		14/42 (33.3%)
General disorders
Non-Cardiac	4/22 (18.2%)		3/20 (15%)		7/18 (38.9%)		7/42 (16.7%)
Other (Not Including Serious) Adverse Events
	Randomized- Pacemaker (CRT-P)		Randomized- Defibrillator (CRT-D)		Observational- Pacemaker (CRT-P)		Observational- Defibrillator (CRT-D)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/22 (40.9%)		6/20 (30%)		2/18 (11.1%)		13/42 (31%)
Cardiac disorders
Cardiac	5/22 (22.7%)		3/20 (15%)		0/18 (0%)		9/42 (21.4%)
General disorders
Non-Cardiac	6/22 (27.3%)		4/20 (20%)		2/18 (11.1%)		5/42 (11.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.