Trial · NCT00763867
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 45
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exercise Capacity, as Determined by Peak Oxygen Uptake | Change from Baseline to Week 24 | |
| Secondary | Exercise Capacity, as Determined by Peak Oxygen Uptake | Change from Baseline to Week 12 | |
| Secondary | Exercise Capacity as Determined by Walk Distance | Change from Baseline to Week 12 | 6 Minute Walk Distance |
| Secondary | Composite Score Reflective of Clinical Status | Measured at Week 24 | Participants ranked sequentially with ranking stratified in one of three tiers based on: 1. Death (lowest tier) The person with the shortest time from randomization to death is given the lowest rank within the tier. 2. Hospitalizations due to cardiovascular or renal causes (middle tier) For patients alive, the ranking within this tier is based on time to hospitalization from randomization date. The person with the first cardiovascular or renal cause hospitalization will be given the lowest rank within the tier. 3. Change in Minnesota Living with Heart Failure Questionnaire (MLWHFQ) from baseline (highest tier) The use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better) |
| Secondary | Exercise Capacity as Determined by Walk Distance | Change from Baseline to Week 24 | 6 minute walk distance |
| Secondary | Cardiopulmonary Exercise Test (CPET) Duration | Change from Baseline to Week 12 | To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement |
| Secondary | Cardiopulmonary Exercise Test (CPET) Duration | Change from Baseline to Week 24 | To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement |
| Secondary | Ventilatory Anaerobic Threshold | Change from Baseline to Week 12 | To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement |
| Secondary | Ventilatory Anaerobic Threshold | Change from Baseline to Week 24 | To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement |
| Secondary | Minnesota Living With Heart Failure Questionnaire (MLWHFQ) | Change from Baseline to Week 12 | The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment. Total score: 0 - 105 Physical subscore: 0 - 40 Emotional subscore: 0 - 25 |
| Secondary | Minnesota Living With Heart Failure Questionnaire | Change from Baseline to Week 24 | The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment. |
| Other | MRI Left Ventricular Mass | Change from Baseline to Week 24 | A decrease in LV Mass is considered an improvement |
| Other | MRI Left Ventricular Mass Index | Change from Baseline to Week 24 | A decrease in Left Ventricular Mass Index is considered an improvement |
| Other | MRI Left Ventricular End Diastolic Volume | Change from Baseline to Week 24 | An increase in Left Ventricular End Diastolic Volume is considered an improvement |
| Other | MRI Left Ventricular End Diastolic Volume Index | Change from Baseline to Week 24 | An increase in Left Ventricular End Diastolic Volume Index is considered an improvement |
| Other | MRI Left Ventricular End Systolic Volume Index | Change from Baseline to Week 24 | An increase in Left Ventricular End Systolic Volume Index is considered an improvement |
| Other | MRI Left Ventricular Ejection Fraction (LVEF) | Change from Baseline to Week 24 | An increase in LVEF is considered an improvement |
| Other | Echocardiogram Left Ventricular Mass | Change from Baseline to Week 24 | A decrease in Left Ventricular Mass is considered an improvement |
| Other | Medial Diastolic Elastance | Change from Baseline to Week 24 | A decrease in Medial Diastolic Elastance is considered an improvement |
| Other | Lateral Diastolic Elastance | Change from Baseline to Week 24 | A decrease in Lateral Diastolic Elastance is considered an improvement |
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.
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GET https://conductscience.org/api/trials/v1/NCT00763867/registered