Trial · NCT07883317
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-related serious adverse events within Day 28 after administration of the investigational exosome preparation. | within Day 28 after administration of the investigational exosome preparation | |
| Secondary | Incidence of all adverse events (AEs) and serious adverse events (SAEs) within Day 28 after administration of the investigational exosome preparation. | within Day 28 after administration of the investigational exosome preparation. | |
| Secondary | Incidence and severity of infusion-related reactions within 24 hours after administration of the investigational exosome preparation, including fever, chills, hypotension, hypersensitivity reactions, and cytokine release syndrome (CRS). | within 24 hours after administration of the investigational exosome preparation | |
| Secondary | Occurrence of clinically significant electrocardiographic abnormalities before and after administration of the investigational exosome preparation | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Occurrence of clinically significant echocardiographic abnormalities before and after administration of the investigational exosome preparation | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Laboratory abnormalities occurring before and after administration of the investigational exosome preparation | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Changes in vital signs (blood pressure, heart rate, respiratory rate, body temperature) | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Incidence of vital sign abnormalities | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score | At 6 months and 12 months after administration of the investigational exosome preparation | KCCQ is a patient-reported health status scale with scores ranging from 0 to 100; higher scores indicate better health-related quality of life. |
| Secondary | Changes from baseline in EuroQol 5-Dimension Questionnaire (EQ-5D) utility index | At 6 months and 12 months after administration of the investigational exosome preparation | EQ-5D is a health status questionnaire. The utility index ranges from -0.594 to 1.0; higher utility index indicates better health status. |
| Secondary | Changes from baseline in New York Heart Association (NYHA) functional class | At 6 months and 12 months after administration of the investigational exosome preparation | NYHA functional classification (Class I, II, III, IV) assessing heart failure symptom severity. |
| Secondary | Changes from baseline in NT-proBNP levels at 6 and 12 months after administration of the investigational exosome preparation | at 6 and 12 months after administration of the investigational exosome preparation | |
| Secondary | Changes from baseline in echocardiographic parameters including LVEF, LVEDD, and LVESD at 6 and 12 months after administration of the investigational exosome preparation | at 6 and 12 months after administration of the investigational exosome preparation | |
| Secondary | Changes from baseline in 6-minute walk test (6MWT) distance at 6 and 12 months after administration of the investigational exosome preparation | at 6 and 12 months after administration of the investigational exosome preparation | |
| Secondary | Time from administration of the investigational exosome preparation to the first occurrence of all-cause death or debilitating stroke | at 12 months after administration of the investigational exosome preparation | |
| Secondary | Time from administration of the investigational exosome preparation to all-cause death | at 12 months after administration of the investigational exosome preparation |
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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GET https://conductscience.org/api/trials/v1/NCT07883317/registered