Trial Outcomes & Findings for Metabolic Mapping and Cardiac Resynchronization (NCT NCT03420833)
NCT ID: NCT03420833
Last Updated: 2025-01-23
Results Overview
LVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, adjusted for the individual's body surface area.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
baseline, 12 months
Results posted on
2025-01-23
Participant Flow
82 participants were enrolled, 6 withdrew prior study randomization.
Participant milestones
| Measure |
CRT-On First, Then CRT-Off
Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period.
Cardiac resynchronization therapy pacemaker (CRT-P): A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.
|
CRT-Off First, Then CRT-On
Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period.
Cardiac resynchronization therapy pacemaker (CRT-P): A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.
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|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
28
|
37
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metabolic Mapping and Cardiac Resynchronization
Baseline characteristics by cohort
| Measure |
CRT-On First, Then CRT-Off
n=38 Participants
Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period.
Cardiac resynchronization therapy pacemaker (CRT-P): A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.
|
CRT-Off First, Then CRT-On
n=38 Participants
Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period.
Cardiac resynchronization therapy pacemaker (CRT-P): A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.
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Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
38 participants
n=7 Participants
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 monthsLVESVI is the volume of blood in the left ventricle at the end of contraction, or systole, adjusted for the individual's body surface area.
Outcome measures
| Measure |
CRT-ON
n=72 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study.
|
CRT-OFF
n=66 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study.
|
|---|---|---|
|
Change in Left Ventricle End-Systolic Volume Index (LVESVI)
|
-11.6 mL/m^2
Standard Deviation 12.8
|
-4.1 mL/m^2
Standard Deviation 12.2
|
PRIMARY outcome
Timeframe: Approximately 12 monthsThis is a composite endpoint; system-related complications could include any of the following: device pocket hematoma, pneumothorax, myocardial perforation, lead dislodgement, lead revision and device-related infection.
Outcome measures
| Measure |
CRT-ON
n=72 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study.
|
CRT-OFF
n=66 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study.
|
|---|---|---|
|
Number of Subjects Experiencing Any System-Related Complications
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Approximately 12 monthsThe total number of subjects hospitalized for heart failure during the study.
Outcome measures
| Measure |
CRT-ON
n=76 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study.
|
CRT-OFF
n=76 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study.
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|---|---|---|
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Number of Subjects Admitted to the Hospital for Heart Failure
|
0 Participants
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0 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 monthsThe NT-proBNP is a substance that is produced in the heart and released when the heart is stretched and working hard to pump blood, measured in pg/mL. The change was calculated as the value at 12 months minus the value at 6 months.
Outcome measures
| Measure |
CRT-ON
n=27 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study.
|
CRT-OFF
n=32 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study.
|
|---|---|---|
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Change in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) by CRT Randomization From 6 Months to 12 Months
|
0.1 pg/mL
Standard Deviation 0.6
|
-0.3 pg/mL
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Approximately 12 monthsIn ventricular tachycardia, abnormal electrical signals in the ventricles cause the heart to beat faster than normal, usually 100 or more beats a minute, out of sync with the upper chambers. Ventricular fibrillation is the most serious cardiac rhythm disturbance. The lower chambers quiver and the heart can't pump any blood, causing cardiac arrest.
Outcome measures
| Measure |
CRT-ON
n=76 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study.
|
CRT-OFF
n=76 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study.
|
|---|---|---|
|
Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater Than 30 Seconds
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsLVEF refers to how well your left ventricle (or right ventricle) pumps blood with each heart beat. Most times, EF refers to the amount of blood being pumped out of the left ventricle each time it contracts. The left ventricle is the heart's main pumping chamber.
Outcome measures
| Measure |
CRT-ON
n=74 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study.
|
CRT-OFF
n=66 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study.
|
|---|---|---|
|
Change in Left Ventricular Ejection Fraction (LVEF)
|
5.3 percent
Standard Deviation 8.2
|
2.2 percent
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Approximately 12 monthsThe total number of subjects to die for any reason during the study.
Outcome measures
| Measure |
CRT-ON
n=76 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study.
|
CRT-OFF
n=76 Participants
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study.
|
|---|---|---|
|
Number of Subjects Who Die in One Year
|
0 Participants
|
3 Participants
|
Adverse Events
CRT-ON
Serious events: 6 serious events
Other events: 44 other events
Deaths: 2 deaths
CRT-OFF
Serious events: 8 serious events
Other events: 29 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
CRT-ON
n=76 participants at risk
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study.
|
CRT-OFF
n=76 participants at risk
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study.
|
|---|---|---|
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Cardiac disorders
Sustained Ventricular Tachycardia
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
2.6%
2/76 • Number of events 2 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Lead dislodgment
|
2.6%
2/76 • Number of events 2 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Electrical Stimulation
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Deep Vein Thrombosis
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
3.9%
3/76 • Number of events 3 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Diaphragmatic Stimulation
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Pneumothorax
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Sepsis
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Syncope
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
2.6%
2/76 • Number of events 2 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Ischemic Stroke
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
Other adverse events
| Measure |
CRT-ON
n=76 participants at risk
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed ON in either the first six months or last six months of the study.
|
CRT-OFF
n=76 participants at risk
Subjects who had their cardiac resynchronization therapy pacemaker (CRT-P) programmed OFF in either the first six months or last six months of the study.
|
|---|---|---|
|
General disorders
Tenderness at implant site
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
0.00%
0/76 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Shortness of breath
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Anemia
|
14.5%
11/76 • Number of events 11 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
10.5%
8/76 • Number of events 8 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Hyperglycemia
|
13.2%
10/76 • Number of events 10 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
13.2%
10/76 • Number of events 10 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Fatigue
|
2.6%
2/76 • Number of events 2 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
2.6%
2/76 • Number of events 2 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Dizziness
|
3.9%
3/76 • Number of events 3 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
2.6%
2/76 • Number of events 2 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
COVID-19
|
3.9%
3/76 • Number of events 3 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Dyspenea
|
3.9%
3/76 • Number of events 3 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
2.6%
2/76 • Number of events 2 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Cough
|
2.6%
2/76 • Number of events 2 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
2.6%
2/76 • Number of events 2 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
|
General disorders
Chest pain
|
10.5%
8/76 • Number of events 8 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
1.3%
1/76 • Number of events 1 • Adverse events were collected on all participants from enrollment through the 48 month follow up visit, for a total of approximately 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place