Trial · NCT02205359
AdaptResponse Clinical Trial
NCT02205359, Not applicable, Completed, Medtronic Cardiac Rhythm and Heart Failure; results first posted 2023-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. AdaptResponse Clinical Trial. Trials, record NCT02205359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02205359
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AdaptResponse Clinical Trial
- NCT number
- NCT02205359
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 3,797 participants, actual
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Conditions
- Heart Failure With Left Bundle Branch Block
- Interventions
- aCRT ON, aCRT OFF
- First posted
- 2014-07-31
- Last updated
- 2023-11-29
- Results first posted
- 2023-11-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation | from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years) | The first occurrence of death or intervention for heart failure decompensation (defined as an event requiring invasive intervention or inpatient hospitalization). |
| Secondary | All-cause Mortality | from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years) | All-cause mortality in the aCRT ON group vs the aCRT OFF group |
| Secondary | Percent of Patients With Interventions for Heart Failure Decompensation | from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years) | First occurence of intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization. |
| Secondary | Clinical Composite Score | CCS at 6 month post randomization | The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened NYHA class (using last observation carried forward), or worsened status on the Global Assessment Score. Also patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged. |
| Secondary | Atrial Fibrillation | from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years) | Occurrence of atrial fibrillation lasting \>6 hours in one day |
| Secondary | Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | from baseline to 24M follow up | The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed. The KCCQ measures Quality of Life on a 0-100 scale with higher scores indicating better QoL |
| Secondary | Change in Quality of Life Measured by the EQ-5D | from baseline to 24M follow up | The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). We calculated the EQ-5D summary index by applying a specific formula providing a valuation to the health states (Shaw et al. Medical Care 2005). For the summary index, value 0 represents health that is valued as equal to death and value 1 represents best possible health. |
| Secondary | All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years | from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years) | All-cause hospital re-admissions within 30 days after discharge from a heart failure admission are reported as number of cases per 100 patient years |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation | from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years) | All randomized subjects | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All-cause Mortality | from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years) | All randomized subjects | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Patients With Interventions for Heart Failure Decompensation | from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years) | all randomized subjects | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Composite Score | CCS at 6 month post randomization | All randomized subjects | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Atrial Fibrillation | from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years) | All randomized subjects | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | from baseline to 24M follow up | All randomized subjects | score on a scale | MEAN |
| SECONDARY | Change in Quality of Life Measured by the EQ-5D | from baseline to 24M follow up | All randomized subjects | score on a scale | MEAN |
| SECONDARY | All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years | from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years) | All randomized subjects | readmissions per 100 patient years | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation | aCRT ON | 430 | Participants | ||
| Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation | aCRT OFF | 470 | Participants | ||
| All-cause Mortality | aCRT ON | 293 | Participants | ||
| All-cause Mortality | aCRT OFF | 327 | Participants | ||
| Percent of Patients With Interventions for Heart Failure Decompensation | aCRT ON | 238 | Participants | ||
| Percent of Patients With Interventions for Heart Failure Decompensation | aCRT OFF | 255 | Participants | ||
| Clinical Composite Score | aCRT ON | Improved | 1250 | Participants | |
| Clinical Composite Score | aCRT OFF | Improved | 1291 | Participants | |
| Clinical Composite Score | aCRT ON | Unchanged | 422 | Participants | |
| Clinical Composite Score | aCRT OFF | Unchanged | 387 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | aCRT ON | 1,810 | |
| Overall Study | STARTED | aCRT OFF | 1,807 | |
| Overall Study | COMPLETED | aCRT ON | 1,117 | |
| Overall Study | COMPLETED | aCRT OFF | 1,096 | |
| Overall Study | NOT COMPLETED | aCRT ON | 693 | |
| Overall Study | NOT COMPLETED | aCRT OFF | 711 |
Source ClinicalTrials.gov
Adverse events2,792
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | aCRT ON | 4 | 1,810 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | aCRT OFF | 1 | 1,807 | 1 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | aCRT ON | 0 | 1,810 | 0 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | aCRT OFF | 1 | 1,807 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | aCRT ON | 1 | 1,810 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | aCRT OFF | 0 | 1,807 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | aCRT ON | 0 | 1,810 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | aCRT OFF | 1 | 1,807 | 1 |
| other | Accelerated idioventricular rhythm | Cardiac disorders | aCRT ON | 1 | 1,810 | 1 |
| other | Accelerated idioventricular rhythm | Cardiac disorders | aCRT OFF | 0 | 1,807 | 0 |
1 to 10 of 2,792Source ClinicalTrials.gov
See all 2,792 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | aCRT ON | 293 | 1,810 |
| Total, all-cause mortality | aCRT OFF | 327 | 1,807 |
| Total, other adverse events | aCRT ON | 773 | 1,810 |
| Total, other adverse events | aCRT OFF | 785 | 1,807 |
| Total, serious adverse events | aCRT ON | 1,072 | 1,810 |
| Total, serious adverse events | aCRT OFF | 1,073 | 1,807 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| aCRT ON vs aCRT OFF: Percent of Patients With Interventions for Heart Failure Decompensation | Trial comparisons |
| aCRT ON vs aCRT OFF: All-cause Mortality | Trial comparisons |
| aCRT ON vs aCRT OFF: Atrial Fibrillation | Trial comparisons |
| aCRT ON vs aCRT OFF: deaths from any cause | Trial comparisons |
| aCRT ON vs aCRT OFF: Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation | Trial comparisons |
| aCRT ON vs aCRT OFF: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02205359
GET https://conductscience.org/api/trials/v1/NCT02205359/results?page=2