Trial Outcomes & Findings for Cardiac Resynchronization in the Elderly (NCT NCT03031847)

NCT ID: NCT03031847

Last Updated: 2023-12-07

Results Overview

Rates of enrollment of participants in this randomized trial

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: At 1 year after start of the study
• Results posted on: 2023-12-07

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Randomized- Pacemaker (CRT-P) Patients assigned to the pacemaker arm will receive CRT-P device	Randomized- Defibrillator (CRT-D) Patients assigned to the defibrillator arm will receive CRT-D device	Observational- Pacemaker (CRT-P) Patients in observational arm that chose CRT-P device	Observational- Defibrillator (CRT-D) Patients in observational arm that chose CRT-D device
Overall Study Death	1	1	2	3
Overall Study Lost to Follow-up	1	1	2	3

Baseline Characteristics

Cardiac Resynchronization in the Elderly

Baseline characteristics by cohort

Measure	Randomized- Pacemaker (CRT-P) n=22 Participants Patients assigned to the pacemaker arm will receive CRT-P device	Randomized- Defibrillator (CRT-D) n=20 Participants Patients assigned to the defibrillator arm will receive CRT-D device	Observational- Pacemaker (CRT-P) n=18 Participants Patients in observational arm that chose CRT-P device	Observational- Defibrillator (CRT-D) n=42 Participants Patients in observational arm that chose CRT-D device	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	20 Participants n=7 Participants	18 Participants n=5 Participants	42 Participants n=4 Participants	102 Participants n=21 Participants
Age, Continuous	80.7 years STANDARD_DEVIATION 4.3 • n=5 Participants	81.4 years STANDARD_DEVIATION 4.9 • n=7 Participants	84.7 years STANDARD_DEVIATION 4.6 • n=5 Participants	80.6 years STANDARD_DEVIATION 4.0 • n=4 Participants	81.5 years STANDARD_DEVIATION 4.5 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	28 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants	74 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	20 Participants n=7 Participants	18 Participants n=5 Participants	42 Participants n=4 Participants	101 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	38 Participants n=4 Participants	94 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment United States	22 participants n=5 Participants	20 participants n=7 Participants	18 participants n=5 Participants	42 participants n=4 Participants	102 participants n=21 Participants

PRIMARY outcome

Timeframe: At 1 year after start of the study

Population: Participants Enrolled

Rates of enrollment of participants in this randomized trial

Outcome measures

Measure	Observational- Pacemaker (CRT-P) n=18 Participants Patients in observational arm that chose CRT-P device	Observational- Defibrillator (CRT-D) n=42 Participants Patients in observational arm that chose CRT-D device	Randomized- Pacemaker (CRT-P) n=22 Participants Patients assigned to the pacemaker arm will receive CRT-P device	Randomized- Defibrillator (CRT-D) n=20 Participants Patients assigned to the defibrillator arm will receive CRT-D device
Enrollment	18 Participants	42 Participants	22 Participants	20 Participants

SECONDARY outcome

Timeframe: At 6 months after enrollment

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

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.

Outcome measures

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

SECONDARY outcome

Timeframe: At 6 months after enrollment

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

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.

Outcome measures

Measure	Observational- Pacemaker (CRT-P) n=12 Participants Patients in observational arm that chose CRT-P device	Observational- Defibrillator (CRT-D) n=32 Participants Patients in observational arm that chose CRT-D device	Randomized- Pacemaker (CRT-P) n=17 Participants Patients assigned to the pacemaker arm will receive CRT-P device	Randomized- Defibrillator (CRT-D) n=17 Participants Patients assigned to the defibrillator arm will receive CRT-D device
QOL2 Rand-36: PCS-T	37.7 score on a scale Standard Deviation 10.5	35.0 score on a scale Standard Deviation 11.2	37.4 score on a scale Standard Deviation 14.5	45.0 score on a scale Standard Deviation 12.4
QOL2 Rand-36: MCS-T	51.6 score on a scale Standard Deviation 10.4	47.7 score on a scale Standard Deviation 13.7	49.0 score on a scale Standard Deviation 13.4	51.4 score on a scale Standard Deviation 10.4

SECONDARY outcome

Timeframe: At 6 months after enrollment

Rates of retention of participants in this randomized trial

Outcome measures

Measure	Observational- Pacemaker (CRT-P) n=18 Participants Patients in observational arm that chose CRT-P device	Observational- Defibrillator (CRT-D) n=42 Participants Patients in observational arm that chose CRT-D device	Randomized- Pacemaker (CRT-P) n=22 Participants Patients assigned to the pacemaker arm will receive CRT-P device	Randomized- Defibrillator (CRT-D) n=20 Participants Patients assigned to the defibrillator arm will receive CRT-D device
Retention	12 Participants	32 Participants	17 Participants	17 Participants

SECONDARY outcome

Timeframe: At 6 months after enrollment

Population: Data was not collected

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

Outcome measures

Outcome data not reported

Adverse Events

Randomized- Pacemaker (CRT-P)

Serious events: 6 serious events

Other events: 9 other events

Deaths: 3 deaths

Randomized- Defibrillator (CRT-D)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 3 deaths

Observational- Pacemaker (CRT-P)

Serious events: 9 serious events

Other events: 2 other events

Deaths: 6 deaths

Observational- Defibrillator (CRT-D)

Serious events: 18 serious events

Other events: 13 other events

Deaths: 17 deaths

Serious adverse events

Measure	Randomized- Pacemaker (CRT-P) n=22 participants at risk Patients assigned to the pacemaker arm will receive CRT-P device.	Randomized- Defibrillator (CRT-D) n=20 participants at risk Patients assigned to the defibrillator arm will receive CRT-D device	Observational- Pacemaker (CRT-P) n=18 participants at risk Patients in observational arm that chose CRT-P device	Observational- Defibrillator (CRT-D) n=42 participants at risk Patients in observational arm that chose CRT-D device
Cardiac disorders Cardiac	9.1% 2/22 • Up to 24 months. 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.	5.0% 1/20 • Up to 24 months. 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.	22.2% 4/18 • Up to 24 months. 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.	33.3% 14/42 • Up to 24 months. 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.
General disorders Non-Cardiac	18.2% 4/22 • Up to 24 months. 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.	15.0% 3/20 • Up to 24 months. 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.	38.9% 7/18 • Up to 24 months. 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.	16.7% 7/42 • Up to 24 months. 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.

Other adverse events

Measure	Randomized- Pacemaker (CRT-P) n=22 participants at risk Patients assigned to the pacemaker arm will receive CRT-P device.	Randomized- Defibrillator (CRT-D) n=20 participants at risk Patients assigned to the defibrillator arm will receive CRT-D device	Observational- Pacemaker (CRT-P) n=18 participants at risk Patients in observational arm that chose CRT-P device	Observational- Defibrillator (CRT-D) n=42 participants at risk Patients in observational arm that chose CRT-D device
Cardiac disorders Cardiac	22.7% 5/22 • Up to 24 months. 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.	15.0% 3/20 • Up to 24 months. 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.	0.00% 0/18 • Up to 24 months. 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.	21.4% 9/42 • Up to 24 months. 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.
General disorders Non-Cardiac	27.3% 6/22 • Up to 24 months. 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.	20.0% 4/20 • Up to 24 months. 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.	11.1% 2/18 • Up to 24 months. 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.	11.9% 5/42 • Up to 24 months. 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.

Additional Information

Eric Pasquantonio

UPMC Presbyterian Hospital

Phone: 4126478210

Email: pasquantonioej@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place