Trial · NCT02391337
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Reported Quality of Life (SF-36) | Primary outcome at 6 months timepoint. | Patient-reported outcomes as assessed by the SF-36 questionnaire physical component score. The physical component score ranges from 0-100 where higher value indicates better outcome. |
| Secondary | Left Ventricular Ejection Fraction | 12 months | The above parameters will be measured using echocardiography and diastolic indices |
| Secondary | Diastolic Function- Measured by the E/e'. | 12 months | The above parameters will be measured using echocardiography and diastolic indices. E/e' - the ratio between early mitral inflow velocity and mitral annular early diastolic velocity. |
| Secondary | B-type Natriuretic Peptide (BNP) at 6 Months. | 6 months | B-type natriuretic peptide (BNP) at 6 months. |
| Secondary | Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months. | 12 months | Composite functional status measures- 6 minute walking distance at 12 months. |
| Secondary | Patient Reported Outcomes- (AFEQT) at 12 Months. | 12 months | As assessed using the AFEQT overall score at 12 months. The range for AFEQT overall score is from 0= complete disability to 100=no disability. |
| Secondary | Patient Reported Outcomes (SF36) Version 2 at 12 Months. | 12 months | As assessed using the SF-36 version 2 global and specific scores at 12 months. All domains presented are between 0 to 100 scale where the higher score indicates better outcomes. |
| Secondary | Patient Reported Outcomes (EQ-5D-5L) | 12 months | As assessed using the EQ-5D-5L summary index questionnaires at both 6 and 12 months. The range for summary index is from -0.594=worst score to 1=best score |
| Secondary | Ambulatory Heart-rate. | Within 12 months | 24 hour ambulatory heart-rate. |
| Other | Cardiovascular Events | 12 months | Number of Participants with hospital admissions for cardiovascular events. |
| Other | Drug Discontinuation Rate | 12 months | the number and extent to which patients discontinue trial drugs |
| Other | Drug Discontinuation Rate Within 12 Months. | 12 months | Number of participants requiring drug discontinuation due to adverse reactions. |
| Other | Hospital Admission Rate | 12 months | A composite of adverse clinical events |
| Other | Retention of Participants | 12 months | Convenience, compliance and cross-over data |
| Other | Preferred Outcome Measures for This Cohort of Patients | 12 months | Establish which are the best measures for these patients |
| Other | Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | 12 months | SF-36 physical function score at 6 and 12 months |
| Other | Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | 12 months | SF-36 overall score at 6 and 12 months |
| Other | Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | 12 months | AFEQT overall score at 6 and 12 months |
| Other | Population-specific Standard Deviations to Enable Sample Size Calculation for a Future Trial Powered to Detect a Difference in Hospital Admissions. | 12 months | LVEF and E/e scores at 6 and 12 months |
| Other | Number of Participants With Unplanned Hospital Admissions. | During the 12 month follow-up period. | Number of Participants with Unplanned Hospital Admissions. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT02391337/registered