A Dose Escalation Study to Evaluate the Effect of RT234 on Cardiopulmonary Haemodynamics in Subjects with Pulmonary Arterial Hypertension.

Respira Therapeutics Australia Pty Ltd0 sites14 target enrollmentAugust 20, 2019

Overview

No summary available.

Registry

who.int

Start Date

August 20, 2019

End Date

January 17, 2020

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Respira Therapeutics Australia Pty Ltd

•1\. Diagnosis of RHC\-confirmed WHO Group 1 PAH in any of the following three categories:
•a) Idiopathic, primary or familial pulmonary arterial hypertension (IPAH, PPH, or FPAH);
•b) PAH associated with one of the following connective tissue diseases (CTD):
•i) Systemic sclerosis (scleroderma)
•ii) Limited scleroderma
•iii) Mixed connective tissue disease
•iv) Systemic lupus erythematosus
•v) Overlap syndrome;
•c) PAH associated with:
•i) Human immunodeficiency virus (HIV) infection with no evidence of opportunistic infection in the preceding 6 months;

•1\. Baseline systemic hypotension, defined as MAP \<50 mmHg or systolic blood pressure (SBP) \<90 mmHg at Screening
•2\. Requirement of intravenous inotropes within 30 days prior to RHC procedure
•3\. Use of oral, topical or inhaled nitrates within 2 weeks prior to RHC procedure
•4\. Uncontrolled systemic hypertension: SBP \>160 mmHg or diastolic blood pressure (DBP) \>100 mmHg during Screening
•5\. History of portal hypertension or chronic liver disease, including active viral replication of hepatitis B and/or hepatitis C, or classified as having moderate to severe hepatic impairment (Child\-Pugh Class B\-C)
•6\. Chronic renal insufficiency as defined by serum creatinine \>2\.5 mg/dL at Screening or requires dialysis
•7\. History of atrial septostomy
•8\. Unrepaired congenital heart disease
•9\. Pericardial constriction; restrictive or congestive cardiomyopathy
•10\. History of left ventricular ejection fraction (EF) \< 40%