Early Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA

Thoraxklinik-Heidelberg gGmbH0 sites38 target enrollmentAugust 7, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension
Sponsor: Thoraxklinik-Heidelberg gGmbH
Enrollment: 38
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

August 7, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Male or female SSc patients with borderline \- PAH and:
•2\.mPAP 21\-24 mmHg, transpulmonary gradient \>11 mmHg, as defined by the current ESC Guidelines, PAWP \<15 mmHg and/or
•3\.Exercise induced elevated mPAP\-values \>30 mmHg, (PAWP \<18 mmHg; TPG \=15 mmHg, as defined in Saggar et al. (2012\)) without left heart or severe lung disease or systemic arterial hypertension
•4\.Adult patients having completed his/her 18th birthday
•5\.Patients with definite diagnosis of Systemic Sclerosis using the scleroderma criteria of the American Rheumatism Association
•6\.SSc \- disease duration \>3 years
•7\.Able to understand and willing to sign the Informed Consent Form
•8\.Negative pregnancy test at the start of the trial and appropriate contraception throughout the study for women with child\-bearing potential.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\.Any connective tissue diseases (CTD) other than SSc
•2\.Pulmonary hypertension (PH) confirmed by right heart catheter (RHC) before enrolment, i.e. mPAP \=25 mmHg at rest
•3\.Patients presenting normal mPAP values, i.e. mPAP\<21 mmHg at rest, and mPAP \=30 mmHg during exercise, and/or PAWP \=15 mmHg at rest or \=18 mmHg during exercise
•4\.Ongoing or a history of \>2 weeks of continued use of therapies that are considered definitive PH treatment: endothelin receptor antagonists (ERA; e.g. bosentan, ambrisentan), phosphodiesterase type 5 inhibitors (PDE5; e.g. sildenafil, tadalafil, vardenafil), and prostanoids (e.g. epoprostenol, treprostinil, iloprost, beraprost) and soluble guanylate cyclase stimulator (e.g. Riociguat). Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted.
•5\.Except for diuretics and corticosteroids medical treatment should not be expected to change 4 weeks prior inclusion into the study and during the entire 12\-week study period.
•6\.Known intolerance to ambrisentan or one of its excipients
•7\.Clinically significant anemia (hemoglobin concentration of less than 75% of the lower limit of normal, LLN)
•8\.Forced vital capacity (FVC) \<60%, forced expiratory volume in first second (FEV1\) \<65%
•9\.Severe interstitial lung disease, idiopathic pulmonary fibrosis
•10\.Renal insufficiency (glomerular filtration rate \[GFR] \<60 mL/min/1\.73m2 at least for the last 3 months before inclusion)