Trial · NCT03738150
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Peak Oxygen Uptake (VO2 Max) at 24 Weeks | Baseline and 24 weeks | Each participant's VO2 max was measured by an invasive cardiopulmonary exercise test (iCPET) at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular Stroke Volume (RV SV) at 24 Weeks | Baseline and 24 weeks | Each participant's RV SV was measured by cardiac MRI at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular End-Systolic Volume (RV ESV) at 24 Weeks | Baseline and 24 weeks | Each participant's RV ESV was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular End-Diastolic Volume (RV EDV) at 24 Weeks | Baseline and 24 weeks | Each participant's RV EDV was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Percent Change From Baseline in Right Ventricular Ejection Fraction (RV EF) at 24 Weeks | Baseline and 24 Weeks | Each participant's RV EF was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular Stroke Volume Index (RV SVI) at 24 Weeks | Baseline and 24 weeks | Each participant's RV SVI was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Right Ventricular (RV) Mass at 24 Weeks | Baseline and 24 weeks | Each participant's RV mass was measured by cardiac MR imaging at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Ventilatory Efficiency (VE/VCO2 Slope) at 24 Weeks | Baseline and 24 weeks | VE/VCO2 slope refers to the slope of the regression line of Minute Ventilation (VE) in liters/minute in the Y-axis and corresponding carbon dioxide production per minute (VCO2) in liters/minute in the X-axis plotted with multiple measurements taken during exercise. Each participant's VE/VCO2 slope at peak exercise was measured by an iCPET at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Cardiac Index at 24 Weeks | Baseline and 24 weeks | Each participant's cardiac index at peak exercise was measured by iCPET at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Mean Pulmonary Arterial Pressure at 24 Weeks | Baseline and 24 weeks | Each participant's pulmonary arterial pressure at peak exercise was measured by iCPET at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Arteriovenous O2 Content Difference (Ca-vO2) at 24 Weeks | Baseline and 24 weeks | Each participant's Ca-vO2 at peak exercise was measured by iCPET at baseline and at 24 weeks. |
| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks | Baseline and 24 weeks | Each participant's PVR, at resting supine, was measured by right heart catheterization (RHC) at baseline and at 24 weeks. |
| Secondary | Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks | Baseline and 24 weeks | 6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicates improvement in basic mobility. |
| Secondary | Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks | Baseline and 24 Weeks | Each participant's laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were measured at baseline and at 24 weeks. |
| Secondary | Change From Baseline in WHO (World Health Organization) Functional Class at 24 Weeks | Baseline and 24 Weeks | The World Health Organization (WHO) functional class describes how severe a person's pulmonary hypertension symptoms are. There are four different classes - I is the mildest and IV the most severe form of pulmonary hypertension. |
| Secondary | Number of Participants With One or More Adverse Events (AEs) | Up to 24 weeks | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Secondary | Number of Participants Who Experienced One or More Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH) | Up to 102 weeks | Events that indicate clinical worsening of PAH include death, need for and/or worsening-related listing for lung and/or heart transplant, need to initiate an approved PAH SOC rescue therapy, PAH-specific hospitalization, or functional deterioration (worsened WHO Functional Class AND 15% decrease in 6MWD). |
| Secondary | Observed Trough Concentration (Ctrough) of Sotatercept at Cycle 9 | Day 1 of Cycle 9 (Each cycle was 21 days.) | Ctrough is the plasma concentration of a drug prior to administration. |
| Secondary | Maximum Plasma Concentration (Cmax) of Sotatercept at Cycle 9 | Day 1 of each 21-day cycle: Cycles 1-9 | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The Cmax parameter is derived from this preliminary popPK modeling. |
| Secondary | Minimum Plasma Concentration (Cmin) of Sotatercept at Cycle 9 | Day 1 of each 21-day cycle: Cycles 1-9 | Cmin is a measure of the minimum amount of drug in the plasma after the dose is given. PopPK modeling approach was used to build a population PK model that captures the totality of the observed data from Cycles 1 to 9. The Cmin parameter is derived from this preliminary popPK modeling. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03738150/registered