Heart Failure
Conditions
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.
Interventions
Patients randomized to the pacemaker arm will receive a CRT-P device.
Patients randomized to the defibrillator arm will receive a CRT-D device.
Sponsors
Samir Saba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment | At 1 year after start of the study | Rates of enrollment of participants in this randomized trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Retention | At 6 months after enrollment | Rates of retention of participants in this randomized trial |
| Health Care Cost | At 6 months after enrollment | Cost of health care between CRT-P and CRT-D recipients. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized- Pacemaker (CRT-P) Patients assigned to the pacemaker arm will receive CRT-P device | 22 |
| Randomized- Defibrillator (CRT-D) Patients assigned to the defibrillator arm will receive CRT-D device | 20 |
| Observational- Pacemaker (CRT-P) Patients in observational arm that chose CRT-P device | 18 |
| Observational- Defibrillator (CRT-D) Patients in observational arm that chose CRT-D device | 42 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 2 | 3 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 | 3 |
Baseline characteristics
| Characteristic | Randomized- Pacemaker (CRT-P) | Randomized- Defibrillator (CRT-D) | Observational- Pacemaker (CRT-P) | Observational- Defibrillator (CRT-D) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 20 Participants | 18 Participants | 42 Participants | 102 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 80.7 years STANDARD_DEVIATION 4.3 | 81.4 years STANDARD_DEVIATION 4.9 | 84.7 years STANDARD_DEVIATION 4.6 | 80.6 years STANDARD_DEVIATION 4 | 81.5 years STANDARD_DEVIATION 4.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 20 Participants | 18 Participants | 42 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 20 Participants | 18 Participants | 18 Participants | 38 Participants | 94 Participants |
| Region of Enrollment United States | 22 participants | 20 participants | 18 participants | 42 participants | 102 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 6 Participants | 8 Participants | 28 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 12 Participants | 34 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 22 | 3 / 20 | 6 / 18 | 17 / 42 |
| other Total, other adverse events | 9 / 22 | 6 / 20 | 2 / 18 | 13 / 42 |
| serious Total, serious adverse events | 6 / 22 | 3 / 20 | 9 / 18 | 18 / 42 |
Outcome results
Primary
Enrollment
Rates of enrollment of participants in this randomized trial
Time frame: At 1 year after start of the study
Population: Participants Enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized- Pacemaker (CRT-P) | Enrollment | 22 Participants |
| Randomized- Defibrillator (CRT-D) | Enrollment | 20 Participants |
| Observational- Pacemaker (CRT-P) | Enrollment | 18 Participants |
| Observational- Defibrillator (CRT-D) | Enrollment | 42 Participants |
Secondary
Health Care Cost
Cost of health care between CRT-P and CRT-D recipients.
Time frame: At 6 months after enrollment
Population: Data was not collected
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.
Time frame: At 6 months after enrollment
Population: Only participants with complete 6-month data for QoL assessments were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized- Pacemaker (CRT-P) | QOL | Emotional QOL | 7.0 score on a scale | Standard Deviation 7.9 |
| Randomized- Pacemaker (CRT-P) | QOL | Overall QOL: MLWHF Questionnaire | 31.5 score on a scale | Standard Deviation 30.3 |
| Randomized- Pacemaker (CRT-P) | QOL | Physical QOL | 14.1 score on a scale | Standard Deviation 13.8 |
| Randomized- Defibrillator (CRT-D) | QOL | Overall QOL: MLWHF Questionnaire | 16.1 score on a scale | Standard Deviation 19.6 |
| Randomized- Defibrillator (CRT-D) | QOL | Emotional QOL | 3.5 score on a scale | Standard Deviation 5.4 |
| Randomized- Defibrillator (CRT-D) | QOL | Physical QOL | 8.2 score on a scale | Standard Deviation 9.4 |
| Observational- Pacemaker (CRT-P) | QOL | Overall QOL: MLWHF Questionnaire | 18.4 score on a scale | Standard Deviation 9.6 |
| Observational- Pacemaker (CRT-P) | QOL | Emotional QOL | 2.9 score on a scale | Standard Deviation 2.8 |
| Observational- Pacemaker (CRT-P) | QOL | Physical QOL | 10.7 score on a scale | Standard Deviation 7.7 |
| Observational- Defibrillator (CRT-D) | QOL | Physical QOL | 18.9 score on a scale | Standard Deviation 11.2 |
| Observational- Defibrillator (CRT-D) | QOL | Overall QOL: MLWHF Questionnaire | 37.8 score on a scale | Standard Deviation 24.3 |
| Observational- Defibrillator (CRT-D) | QOL | Emotional QOL | 7.5 score on a scale | Standard Deviation 7 |
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.
Time frame: At 6 months after enrollment
Population: Only participants with complete 6-month data for QoL assessments were reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized- Pacemaker (CRT-P) | QOL2 | Rand-36: PCS-T | 37.4 score on a scale | Standard Deviation 14.5 |
| Randomized- Pacemaker (CRT-P) | QOL2 | Rand-36: MCS-T | 49.0 score on a scale | Standard Deviation 13.4 |
| Randomized- Defibrillator (CRT-D) | QOL2 | Rand-36: MCS-T | 51.4 score on a scale | Standard Deviation 10.4 |
| Randomized- Defibrillator (CRT-D) | QOL2 | Rand-36: PCS-T | 45.0 score on a scale | Standard Deviation 12.4 |
| Observational- Pacemaker (CRT-P) | QOL2 | Rand-36: PCS-T | 37.7 score on a scale | Standard Deviation 10.5 |
| Observational- Pacemaker (CRT-P) | QOL2 | Rand-36: MCS-T | 51.6 score on a scale | Standard Deviation 10.4 |
| Observational- Defibrillator (CRT-D) | QOL2 | Rand-36: PCS-T | 35.0 score on a scale | Standard Deviation 11.2 |
| Observational- Defibrillator (CRT-D) | QOL2 | Rand-36: MCS-T | 47.7 score on a scale | Standard Deviation 13.7 |
Secondary
Retention
Rates of retention of participants in this randomized trial
Time frame: At 6 months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized- Pacemaker (CRT-P) | Retention | 17 Participants |
| Randomized- Defibrillator (CRT-D) | Retention | 17 Participants |
| Observational- Pacemaker (CRT-P) | Retention | 12 Participants |
| Observational- Defibrillator (CRT-D) | Retention | 32 Participants |