Trial · NCT05825417
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Right Ventricular Stroke Volume (RVSV) flow on each therapy measured by MRI RSVS (flow) on each therapy measured by MRI | Baseline to Week 12 of each crossover period | This provides a robust, objective assessment of clinical efficacy which, if met, will mean that a change in therapy has provided a clinically meaningful change in physiology |
| Primary | Daily Hemodynamic Detection of Treatment Response During Sotatercept Escalation | Baseline (Week 0) through Week 24 | Within-patient changes in continuous, remote-monitored Total Pulmonary Resistance (TPR), mean Pulmonary Artery Pressure (mPAP), Cardiac Output (CO), Stroke Volume (SV), and Heart Rate (HR) detected by the CardioMEMS sensor following treatment escalation with sotatercept, correlated with end-of-treatment RVSV measured by cardiac MRI. |
| Secondary | Haemodynamics - Total Pulmonary Resistance (TPR) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks. | Change in TPR (Woods Units) on each therapy to determine clinical efficacy |
| Secondary | Haemodynamics - mean Pulmonary Artery Pressure (mPAP) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks. | Change in mPAP (mmHg) on each therapy to determine clinical efficacy |
| Secondary | Haemodynamics - Cardiac Output (CO) | Part 1 : From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks. | Change in CO (L/min) on each therapy to determine clinical efficacy |
| Secondary | Haemodynamics - Cardiac Index | Part 1 : From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | Change in cardiac index (L/min/m\^2) on each therapy to determine clinical efficacy |
| Secondary | Haemodynamics - Stroke Volume (SV) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks. | Change in SV (mL) on each therapy to determine clinical efficacy |
| Secondary | Haemodynamics - Heart Rate (HR) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks. | Change in HR (bpm) on each therapy to determine clinical efficacy |
| Secondary | 6 Minute Walk Test | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks. | Change on each therapy to determine clinical efficacy |
| Secondary | NTpro-BNP | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks. | Change on each therapy to determine clinical efficacy |
| Secondary | MRI - Right Ventricular Ejection Fraction (RVEF) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | RVEF (%) on each therapy to determine clinical efficacy |
| Secondary | MRI - Right Ventricular End Systolic Volume (RVESV) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | RVESV (mL/m\^2) on each therapy to determine clinical efficacy |
| Secondary | MRI - Right Ventricular End Diastolic Volume (RVEDV) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | RVEDV (mL/m\^2) on each therapy to determine clinical efficacy |
| Secondary | MRI - Right Ventricular Stroke Volume (RVSV) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | RVSV (mL) on each therapy to determine clinical efficacy |
| Secondary | MRI - Left Ventricular Volume Fraction (LVEF) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | LVEF (%) on each therapy to determine clinical efficacy |
| Secondary | MRI - Left Ventricular End Systolic Volume (LVESV) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | LVESV (mL/m\^2) on each therapy to determine clinical efficacy |
| Secondary | MRI - Left Ventricular End Diastolic Volume LVEDV | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | LVEDV (mL/m\^2) on each therapy to determine clinical efficacy |
| Secondary | MRI - Left Ventricular Stroke Volume (LVSV) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | LVSV (mL) on each therapy to determine clinical efficacy |
| Secondary | MRI - Left Ventricular Stroke Volume (LVSV) flow | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | LVSV flow on each therapy to determine clinical efficacy |
| Secondary | Patient Reported Outcomes (PRO) - Quality of Life (QoL) (EmPHasis-10) | Part 1: From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks Part 2: From baseline and area under the curve to 3 weeks, 6 weeks, 12 weeks, 18 weeks, and 24 weeks | Change of QoL score on each therapy to determine clinical efficacy. This will be done using EmPHasis-10 questionnaire (10 questions using a 0 (poor) - 5 (good) scale) |
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.
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