Trial · NCT05384847
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in the presence of clinical arrhythmias | Baseline, Days 1*, 2*, 3*, 4*, 5*, 6 weeks, 3 months, 6 months, 12 months | An electrocardiogram will be performed during each study visit and the presence of any Clinical arrhythmias such as ectopy, atrial fibrillation, ventricular arrhythmias, ICD firing will be documented. \*Days 1 through 5 apply only to those who are admitted to the GCRC unit. |
| Primary | The number of participants with Angina, acute coronary syndrome, death during the first week | During the first week of treatment period | The total number of subject's events during the first week of the treatment period will be recorded |
| Secondary | Change in left ventricular ejection fraction (LVEF) | Baseline, Day 45, Day 90 | An echocardiogram will be performed at specific study visits and LVEF will be measured |
| Secondary | Change in 6-minute walk distance (6MWD) | Baseline, Day 45, Day 90 | Two 6-minute walk tests will be completed at least 2 hours apart to establish a baseline. The mean of the 2 distances will be used as the baseline. The six-minute walk test requires a 100-ft hallway. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. The six-minute walk test serves as a standardized test for functional capacity quantification of HF patients and is predictive of adverse cardiovascular outcomes. Most patients do not achieve maximal exercise capacity during the 6-minute walk test; instead, they choose their own intensity of exercise and can stop and rest during the test. |
| Secondary | Changes in New York Heart Association (NYHA) classification | Baseline, Day 45, Day 90 | Participants will be asked about exertional symptoms for NYHA functional categorization of HF symptoms at all time points. Symptom-based scores range from I to IV. The NYHA classification system also includes an objective assessment of cardiovascular disease severity, which ranges from A-D. Differences between treatment and control arms over time will be analyzed as well as within arms over time. |
| Secondary | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline, Day 45, Day 90 | This is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and quality of life limitation due to HF. Scores range from 0 to 100. For the KCCQ overall summary score, a small but clinically meaningful change is ≥ 5 points. |
| Secondary | Changes in Brain natriuretic peptide (BNP) levels | Baseline, Day 45, Day 90 | -B-type natriuretic peptide (BNP) will be measured at specific study visits. Differences between treatment and control arms over time will be analyzed as well as within arms over time. |
| Other | Changes in the Left ventricular end-systolic volume (LVESV) and Left ventricular end-diastolic volume (LVEDV) | Baseline, Day 45, Day 90 | An echocardiogram will be performed at specific study visits and LVESV and LVEDV will be measured. |
| Other | Changes Left ventricular end-systolic volume index (LVESVI) and end-diastolic volume index (LVEDVI) | Baseline, Day 45, Day 90 | An echocardiogram will be performed at specific study visits and LVESVI and LVEDVI will be measured. |
| Other | Changes in the LV posterior wall (LVPW) thickness by speckle-tracking echocardiography | Baseline, Day 45, Day 90 | An echocardiogram will be performed at specific study visits where the LV posterior wall (LVPW) thickness by 2D echocardiography (longitudinal and circumferential strain and strain rate). |
| Other | Changes in longitudinal and circumferential strain by speckle-tracking echocardiography | Baseline, Day 45, Day 90 | An echocardiogram will be performed at specific study visits where longitudinal and circumferential strain will be measured by 2D echocardiography (and strain rate). |
| Other | Changes in the strain rate by speckle-tracking echocardiography | Baseline, Day 45, Day 90 | An echocardiogram will be performed at specific study visits where the strain rate will be measured by 2D echocardiography |
| Other | Composite of all-cause mortality | After 1 week of study drug administration up to 12 months | The total number of subject deaths after the first week of treatment up to 12 months will be recorded |
| Other | Number of participants with hospital admission due to acute coronary syndrome (ACS) and all-cause HF admissions after first week | After 1 week of study drug administration up to 12 months | Participants will be asked about any ACS and HF hospital admission during each study visit, in addition, electronic medical records (EMR) will be reviewed periodically to document any ACS and HF hospital admission. |
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
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