Trial · NCT02290613
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Pulmonary Arterial Pressure Change From Baseline | baseline, 6 months | Determine whether mean pulmonary arterial pressure of SSc patients with borderline - PAH (mPAP 21 24 mmHg, TPG \>11 mmHg) can be reduced by 3 mm Hg (absolute change baseline vs. 6 months; equals 15%) following treatment with ambrisentan 10 mg/die (initiated with 5 mg/die and elevated up to 10 mg/die) over 6 months (primary endpoint) compared to baseline and placebo. |
| Secondary | Mean Pulmonary Arterial Pressure During Exercise Change From Baseline | baseline, 6 months | Determine whether exercise induced elevated mean pulmonary arterial pressure-values (\>30 mmHg without left heart or severe lung disease or systemic arterial hypertension) can be reduced by ambrisentan 10 mg/die over 6 months. |
| Secondary | 6-Minute-walking Test | baseline, 6 months | |
| Secondary | Borg Dyspnea Index | baseline, 6 months | measured directly after 6 minute walking distance; The Borg dyspnea index is an standardized scale which reports the subjective feeling of exertion from 0 (no dyspnea) to 10 (maximal feeling of dyspnea). |
| Secondary | Quality of Life (SF-36) Questionnaire | baseline, 6 months | SF-36 Questionnaire; physical Summation score; All scores and subscores of the SF-36 questionnaire range from 0 (low quality of life) to 100 (high quality of life). The physical Summation score is a compound score including the physical dimensions of the SF-36. |
| Secondary | Lung Function | baseline,6 months | DLCo (diffusing capacity or transfer factor of the lung for carbon monoxide (CO)) |
| Secondary | Lung Function | baseline, 6 months | DLCo (diffusing capacity or transfer factor of the lung for carbon monoxide (CO)) |
| Secondary | Lung Function | baseline, 6 months | FVC (forced vital capacity) |
| Secondary | Lung Function | baseline, 6 months | FEV1 (forced expiratory volume in one second) |
| Secondary | Lung Function | baseline, 6 months | TLC (total lung capacity) |
| Secondary | Lung Function | baseline, 6 months | residual volume |
| Secondary | Echocardiography | baseline, 6 months | RA-area (right atrial area) |
| Secondary | Echocardiography | baseline, 6 months | RV-area (right ventricular area) |
| Secondary | Echocardiography | baseline, 6 months | TAPSE (tricuspid annular plane systolic excursion) |
| Secondary | Echocardiography | baseline, 6 months | sPAP (systolic pulmonary arterial pressure) |
| Secondary | WHO-functional Class | baseline | The World Health Organization functional class includes four categories with 1. Patients with Pulmonary Hypertension but without any resulting limitation of physical activity. 2. Patients with Pulmonary Hypertension resulting in slight limitation of physical activity. 3. Patients with Pulmonary Hypertension resulting in marked limitation of physical activity. 4. Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. |
| Secondary | Hemodynamics | change from baseline to 6 months | right atrial pressure |
| Secondary | Hemodynamics | baseline, 6 months | pulmonary vascular resistance |
| Secondary | Hemodynamics | baseline, 6 months | cardiac output (CO) |
| Secondary | Hemodynamics | baseline, 6 months | cardiac index (CI) |
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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