Trial Outcomes & Findings for Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy (NCT NCT02164721)
NCT ID: NCT02164721
Last Updated: 2020-03-04
Results Overview
The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
6 months post implant
Results posted on
2020-03-04
Participant Flow
Participant milestones
| Measure |
CRT-D (Defibrillator)
Implantation of a three-lead Cardiac Resynchronization Therapy -Defibrillator (CRT-D) in all registered patients
Three-lead CRT-D (Defibrillator): The three-lead CRT-D (Defibrillator) will consist of a pulse generator, a right atrial lead, a right ventricular lead and a left ventricular lead.
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|---|---|
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Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In one patient, the presence of nonischemic cardiomyopathy was unknown.
Baseline characteristics by cohort
| Measure |
CRT-D (Defibrillator)
n=30 Participants
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
Three-lead CRT-D (Defibrillator): The three-lead CRT-D (Defibrillator) will consist of a pulse generator, a right atrial lead, a right ventricular lead and a left ventricular lead.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=30 Participants
|
|
Age, Continuous
|
66 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
|
Number of participants with Nonischemic cardiomyopathy
|
29 Participants
n=29 Participants • In one patient, the presence of nonischemic cardiomyopathy was unknown.
|
|
Median Electrocardiographic depolarization duration (QRS) after consent
|
152 ms
n=30 Participants
|
|
Number of participants with Left bundle branch block (LBBB) after consent
|
30 Participants
n=30 Participants
|
|
Sinus rhythm after consent
|
29 Participants
n=30 Participants
|
|
Number of participants with Diabetes
|
6 Participants
n=30 Participants
|
|
Number of participants with Hypertension
|
17 Participants
n=30 Participants
|
|
Number of participants with a History of ventricular arrhythmias
|
3 Participants
n=30 Participants
|
|
Number of participants with a history of atrial arrhythmias
|
8 Participants
n=30 Participants
|
|
Number of participants with Anthracycline history
|
24 Participants
n=29 Participants • One patient had missing data for anthracycline history.
|
|
Median Time since cancer diagnosis
|
13.8 years
n=30 Participants
|
|
Median Age at cancer diagnosis
|
52 years
n=30 Participants
|
|
Number of participants with History of breast cancer
|
22 Participants
n=30 Participants
|
|
Number of participants with a History of leukemia or lymphoma
|
6 Participants
n=30 Participants
|
|
Number of participants with a History of sarcomas
|
2 Participants
n=30 Participants
|
|
Median blood urea nitrogen levels
|
20 mg/dl
n=27 Participants • Data were available in 27 out of 30 participants.
|
|
Median Creatinine Levels
|
0.95 mg/dl
n=28 Participants • Data were available in 28 out of 30 participants.
|
|
New York Heart Association class, II
|
17 Participants
n=30 Participants
|
|
New York Heart Association class, III
|
13 Participants
n=30 Participants
|
|
Median Blood pressure, systolic
|
121.5 mm Hg
n=30 Participants
|
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Median Blood pressure, diastolic
|
70.5 mm Hg
n=30 Participants
|
|
Number of participant taking a Beta-Blocker
|
28 Participants
n=30 Participants
|
|
Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)
|
23 Participants
n=30 Participants
|
|
Number of participants taking a Loop diuretic
|
28 Participants
n=30 Participants
|
|
Number of participants taking Aldosterone
|
15 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 6 months post implantPopulation: Change in left ventricular ejection fraction (LVEF) from baseline to six months was analyzed with 26 patients with data available.
The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months
Outcome measures
| Measure |
CRT-D (Defibrillator)
n=26 Participants
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
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|---|---|
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Change in Left Ventricular Ejection Fraction
|
10.6 percentage of LVEF
Standard Deviation 6.6
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SECONDARY outcome
Timeframe: 6 months post implantPopulation: Event rate of all-cause mortality is described.
Number of Participants with All-Cause Mortality in CRT-D patients
Outcome measures
| Measure |
CRT-D (Defibrillator)
n=30 Participants
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
|
|---|---|
|
Number of Participants With All-Cause Mortality
|
0 participants
|
SECONDARY outcome
Timeframe: 6 months post implantPopulation: Describe 23 patients with data available on LVEDV change
Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end diastole (LVEDV) between baseline and six months
Outcome measures
| Measure |
CRT-D (Defibrillator)
n=23 Participants
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
|
|---|---|
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Effects of CRT Therapy on Left Ventricular Volume at End Diastole
|
-31.9 ml
Standard Deviation 22.5
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SECONDARY outcome
Timeframe: 6 months post implantPopulation: Describe changes in LVESV in 23 patients with data available
Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end systole (LVESV) between baseline and six months
Outcome measures
| Measure |
CRT-D (Defibrillator)
n=23 Participants
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
|
|---|---|
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Effects of CRT Therapy on Left Ventricular Volume at End Systole
|
-37.0 ml
Standard Deviation 20.4
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OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post implantPopulation: Improvement in NYHA functional class between baseline and six months (yes/no) in 29 participants with data available.
Improvement in NYHA functional class between baseline and six months (yes/no), ie. change from NYHA class III to NYHA II.
Outcome measures
| Measure |
CRT-D (Defibrillator)
n=29 Participants
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
|
|---|---|
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Change in New York Heart Association (NYHA) Functional Class
|
12 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post implantPopulation: Change in left atrial size between baseline and six months was analyzed in 26 patients with data available.
Change in left atrial size between baseline and six months
Outcome measures
| Measure |
CRT-D (Defibrillator)
n=26 Participants
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
|
|---|---|
|
Change in Left Atrial Size
|
-12.6 ml
Standard Deviation 9.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post implantPopulation: Frequency of heart failure described in the study population.
Effects of CRT on the frequency of heart failure with end point of inpatient hospitalization with augmented treatment for heart failure
Outcome measures
| Measure |
CRT-D (Defibrillator)
n=30 Participants
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
|
|---|---|
|
Effects of CRT on Frequency of Heart Failure
|
1 participants
|
Adverse Events
CRT-D (Defibrillator)
Serious events: 6 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CRT-D (Defibrillator)
n=30 participants at risk
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
|
|---|---|
|
Cardiac disorders
Device Infection
|
3.3%
1/30 • Number of events 1 • We have collected data on adverse events during the 6 months follow-up in the study.
The definition of adverse event and/or serious adverse event is the same as on clinicaltrials.gov.
|
|
Cardiac disorders
Pericardial effusion
|
3.3%
1/30 • Number of events 1 • We have collected data on adverse events during the 6 months follow-up in the study.
The definition of adverse event and/or serious adverse event is the same as on clinicaltrials.gov.
|
|
Cardiac disorders
Inappropriate device therapy
|
3.3%
1/30 • Number of events 1 • We have collected data on adverse events during the 6 months follow-up in the study.
The definition of adverse event and/or serious adverse event is the same as on clinicaltrials.gov.
|
|
Nervous system disorders
Shingles
|
3.3%
1/30 • Number of events 1 • We have collected data on adverse events during the 6 months follow-up in the study.
The definition of adverse event and/or serious adverse event is the same as on clinicaltrials.gov.
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|
Infections and infestations
Parotitis
|
3.3%
1/30 • Number of events 1 • We have collected data on adverse events during the 6 months follow-up in the study.
The definition of adverse event and/or serious adverse event is the same as on clinicaltrials.gov.
|
|
Cardiac disorders
Heart failure
|
3.3%
1/30 • Number of events 1 • We have collected data on adverse events during the 6 months follow-up in the study.
The definition of adverse event and/or serious adverse event is the same as on clinicaltrials.gov.
|
Other adverse events
| Measure |
CRT-D (Defibrillator)
n=30 participants at risk
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
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|---|---|
|
Cardiac disorders
Hypertension
|
6.7%
2/30 • Number of events 2 • We have collected data on adverse events during the 6 months follow-up in the study.
The definition of adverse event and/or serious adverse event is the same as on clinicaltrials.gov.
|
|
Cardiac disorders
Atrial fibrillation/flutter
|
6.7%
2/30 • Number of events 2 • We have collected data on adverse events during the 6 months follow-up in the study.
The definition of adverse event and/or serious adverse event is the same as on clinicaltrials.gov.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place