Trial · NCT04972656
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of diagnostic PAH (mPAP ≥25 mmHg) | baseline, 1 year | Determine whether mean pulmonary arterial pressure of patients with borderline - PAH (mPAP 21-24 mmHg) can be reduced by 3 mm Hg (absolute change baseline vs. 1 year; equals 15%) following treatment with ambrisentan 10 mg/die (initiated with 5 mg/die and elevated up to 10 mg/die) over 1 year (primary endpoint) compared to baseline and placebo. |
| Primary | Change of Pulmonary vascular resistance | baseline, 1 year | Pulmonary vascular resistance by right heart catheterization |
| Secondary | Re-hospitalization due to clinical worsening | baseline, 3 years | Re-hospitalization is defined as clinical manifestations of worsening PAH requiring re-hospitalization in order to add intravenous pharmacological agents (inotrope or vasodilator), mechanical intervention or ultrafiltration, hemofiltration, or dialysis. |
| Secondary | All-cause mortality | baseline, 3 years | |
| Secondary | 6-Minute-walking Test | baseline, 1 year | |
| Secondary | Right atrial pressure by right heart catheterization | baseline, 1 year | |
| Secondary | Cardiac output (CO) by right heart catheterization | baseline, 1 year | |
| Secondary | Cardiac index (CI) by right heart catheterization | baseline, 1 year | |
| Secondary | RA-area (right atrial area) by echocardiography | baseline, 1 year | |
| Secondary | RV-area (right ventricular area) by echocardiography | baseline, 1 year | |
| Secondary | Tei by echocardiography | baseline, 1 year | Tei |
| Secondary | TAPSE (tricuspid annular plane systolic excursion) by echocardiography | baseline, 1 year | |
| Secondary | sPAP (systolic pulmonary arterial pressure) by echocardiography | baseline, 1 year |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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GET https://conductscience.org/api/trials/v1/NCT04972656/registered