Trial · NCT05469165
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in mitral regurgitation severity | Baseline, 3 months | Incidence of more than mild MR (MRI regurgitant fraction ≥ 20%) at 3 months (measured by MRI) |
| Secondary | Change in mitral leaflet size | Baseline, 3 months | Mitral leaflet size (3D echo) and its variation vs baseline (measured by echocardiography) |
| Secondary | Change in mitral regurgitation grade | Baseline, 3 months | Mitral regurgitation grade (measured by echocardiography). Mitral regurgitation is graded on a scale of I-IV (grade I (mild MR), grade II (moderate MR), grade III (moderate-to-severe MR) and grade IV (severe MR)). A higher mitral regurgitation grade is generally associated with a worse outcome for the patient. |
| Secondary | Change in left ventricle size | Baseline, 3 months | Left ventricle size (measured by MRI ) |
| Secondary | Change in left ventricle function | Baseline, 3 months | Left ventricle function (measured by MRI ) |
| Secondary | Incidence of other valve regurgitation | 3 months | Incidence of other valve regurgitation (more than mild) (measured by echocardiography) |
| Secondary | Change in mitral valve thickness | Baseline, 3 months | Mitral valve thickness (measured by echocardiography) |
| Secondary | Adverse events | 3 months and 1 year | Composite of: Mortality, Heart failure requiring hospital admission, Mitral valve intervention (surgical/percutaneous) |
| Secondary | Ischemic events | 3 months and 1 year | stroke and myocardial infarction |
| Secondary | Bleeding events | 3 months and 1 year | Bleeding Academic Research Consortium (BARC) definition |
| Secondary | Change in weight of participants | Baseline, 3 months | Weight gain during therapy (self-assessment by participants) |
| Secondary | Change in the patient's perception of their health status | Baseline, 3 months | Self-administered questionnaire : Kansas City Cardiomyopathy Questionnaire (KCCQ). All score are represented on a 0-to-100-point scale (lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life). |
| Secondary | Change in the functional capacity of participants | 3 months, 1 year | 6-minutes walk test |
| Secondary | Incidence of sedation | Baseline, 3 months | Incidence of sedation (reported by participants) |
| Secondary | Change in depression score | Baseline, 3 months | Self-administered questionnaire: Patient Health Questionnaire (PHQ-9). The Patient Health Questionnaire has a scale of 0-27, with higher scores indicating a worse outcome for the patient, with more severe depression symptoms. |
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/NCT05469165/registered