Trial · NCT06868381
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with resolution of cardiac FDG uptake on PET-CT | From baseline to end of treatment at 16 weeks | Resolution of FDG uptake will be determined by the consensus of two blinded nuclear medicine radiologists, in accordance with current SNMMI and ASNC guidelines |
| Secondary | Percent change in FDG avidity (SUVmax) in the cardiac lesion with greatest FDG avidity on PET-CT | From baseline to 8 weeks and end of treatment at 16 weeks | |
| Secondary | Percent change in total cardiac metabolic activity on FDG PET-CT | From baseline to 8 weeks and end of treatment at 16 weeks | Total cardiac metabolic activity is total lesion glycolysis within the heart |
| Secondary | Proportion of patients with resolution of extracardiac FDG uptake on PET-CT | From baseline to 8 weeks and end of treatment at 16 weeks | |
| Secondary | Percent change in FDG avidity (SUVmax) in up to six extracardiac lesions on PET-CT | From baseline to 8 weeks and end of treatment at 16 weeks | |
| Secondary | Percent change in total extracardiac metabolic activity on FDG PET-CT | From baseline to 8 weeks and end of treatment at 16 weeks | Total extracardiac metabolic activity is total lesion glycolysis of extracardiac disease |
| Secondary | Proportion of patients with resolution of cardiac FDG uptake on PET-CT | From baseline to 8 weeks and end of follow-up at 28 weeks | |
| Secondary | Change in sarcoidosis disease activity assessment | From baseline to 8 weeks and end of treatment at 16 weeks | Sarcoidosis disease activity assessed with King's Sarcoidosis Questionnaire. Total score range: 0 to 100, with 100 indicating the highest quality of life |
| Secondary | Change in fatigue assessment | From baseline to 8 weeks and end of treatment at 16 weeks | Fatigue assessed with FACIT-F. Total score range: 0-52, lower scores correspond with more fatigue |
| Secondary | Change from Baseline in Physician Disease Activity Visual Analogue Scale (VAS) | From baseline to 8 weeks and end of treatment at 16 weeks | Physician rates patient's disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state |
| Secondary | Change from Baseline in Patient Disease Activity Visual Analogue Scale (VAS) | From baseline to 8 weeks and end of treatment at 16 weeks | Patient rates their disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state |
| Secondary | Changes in ACE laboratory assessment | From baseline to 8 weeks and end of treatment at 16 weeks | |
| Secondary | Changes in high-sensitivity troponin I laboratory assessment | From baseline to 8 weeks and end of treatment at 16 weeks | |
| Secondary | Changes in NT-proBNP laboratory assessment | From baseline to 8 weeks and end of treatment at 16 weeks | |
| Secondary | Changes in total IgG laboratory assessment | From baseline to 8 weeks and end of treatment at 16 weeks | |
| Secondary | Changes in ESR laboratory assessment | From baseline to 8 weeks and end of treatment at 16 weeks | |
| Secondary | Changes in CRP laboratory assessment | From baseline to 8 weeks and end of treatment at 16 weeks | |
| Secondary | Number of participants with safety endpoints of interest | From screening to end of follow-up at 28 weeks | Safety endpoints of interest include hospitalization for cardiac events, implantation of a left ventricular assist device (LVAD), cardiac transplantation, mortality |
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/NCT06868381/registered