Phase 4
Completed N=12
Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan
Systemic Sclerosis · Shortness of Breath · Hypertension
Source: ClinicalTrials.gov NCT01051960 ↗
Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Nov 2020
Primary outcomePrimary: Change in Exercise Pulmonary Hemodynamics From Baseline to Week 24 — 37.4 mmHg — p=.0008
◆ Published Evidence
Highly cited
105citations · ~8 / year
Brief report: effect of ambrisentan treatment on exercise-induced pulmonary hypertension in systemic sclerosis: a prospective single-center, open-label pilot study.
Summary
The purpose of this study is to determine the clinical characteristics and hemodynamic profiles that predict exercise induced pulmonary hypertension in 15 patients with systemic sclerosis. The study also aims to determine the effectiveness of Ambrisentan for subjects with exercise induced Pulmonary Arterial Hypertension (PAH) with scleroderma
Linked Publications
-
Brief report: effect of ambrisentan treatment on exercise-induced pulmonary hypertension in systemic sclerosis: a prospective single-center, open-label pilot study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Exercise Pulmonary Hemodynamics From Baseline to Week 24 |
37.4 | .0008 sig |
| SECONDARY Change in Distance Walked in Six Minutes From Baseline to 24 Week |
44.5 | 0.00007 sig |
| SECONDARY Quality of Life (QOL) Based on SF36 and HAQ-DI |
— | — |
| SECONDARY HAQ-DI (Health Assessment Questionnaire Disability Index) |
1.12 | — |
| SECONDARY St. George's Respiratory Questionnaire |
13.2 | — |
Eligibility Criteria
Inclusion Criteria
- Systemic Sclerosis diagnosed by the American College of Rheumatology consensus statement including any of the following:
- Limited
- Diffuse
- Sine Scleroderma
- Patients must be willing and able to undergo right heart catheterization with lower extremity cycle ergometry
- Mean pulmonary artery pressure (mPAP) > 30mmHg with exercise; PCWP ≤ 15mmHg on RHC at rest
- Men and women, ages 18 years of age or older
- Standard adjunctive medications will be allowed concurrently in this study at the discretion of the treating pulmonologist and rheumatologist, including digoxin, diuretics, anticoagulants (e.g. warfarin), stable immunosuppression or other anti-fibrotic therapy for at least one month prior to enrollment
Exclusion Criteria
- Resting PAH (mPAP > 25mmHg) on right heart catheterization
- Other known causes of PAH including prior venous thromboembolism, HIV infection, chronic liver disease with portal hypertension, left ventricular systolic dysfunction (e.g. LVEF 2.5mg/dL).
- Uncontrolled sleep apnea.
Data sourced from ClinicalTrials.gov (NCT01051960) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.