Trial · NCT00094302
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Cardiovascular Mortality | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Aborted Cardiac Arrest | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of aborted cardiac arrest |
| Secondary | Hospitalization for the Management of Heart Failure | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of a hospitalization for the management of heart failure |
| Secondary | All-cause Mortality | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Cardiovascular-related Hospitalization | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | Hospitalization for MI, stroke or the management of heart failure, whichever occurred first |
| Secondary | Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline. | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline. |
| Secondary | Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline. | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline |
| Secondary | Myocardial Infarction | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of myocardial infarction |
| Secondary | Stroke | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of stroke |
| Secondary | Deterioration of Renal Function | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.) |
| Secondary | Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | |
| Secondary | Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire. | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter. |
| Secondary | Quality of Life, as Measured by the EuroQOL Visual Analog Scale. | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter. |
| Secondary | Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire. | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group. The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - "Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition?" Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina. |
| Secondary | Depression Symptoms, as Measured by Patient Health Questionnaire. | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada. |
| Secondary | Hospitalization for Any Reason | Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | First incidence of a hospitalization for any reason |
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/NCT00094302/registered