Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)
Status:
Completed
Trial end date:
2017-12-31
Target enrollment:
Participant gender:
Summary
Trial Design Patients with borderline PAH indicated by borderline mPAP values will be
included in this single centre study. This clinical investigation is performed as a
Proof-of-Concept (PoC) investigator initiated trial (IIT) using a prospective, randomized,
double-blind, parallel group, placebo-controlled, phase IIA clinical study design. On their
first visit their medical history will be obtained and physical examination will be
conducted. Moreover, an electrocardiogram (ECG), laboratory testing (NT-proBNP, uric acid and
other laboratory tests), echocardiography at rest and right heart catheterization will be
carried out. If patients have been identified within the last 6 months before screening
investigations by right heart catheterization, the measurements are considered valid as
baseline investigations and will not be repeated. If patients fulfill the inclusion criteria
and still suffer from borderline mPAP values they will be invited to join the study. The
clinical investigations will begin within 28 days. The prospective study will comprise a 6
months study period (180 ±2 weeks) plus the screening phase up to 28 days and a follow-up
phase of 30 ±7 days.