Pulmonary arterial hypertension MedDRA version: 21.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Cardiorentis AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients 18 to 75 years of age 2. Known diagnosis of PAH (idiopathic, hereditary, drug-associated, due to connective tissue disease, simple congenital heart defects closed >1 year) with a) PVR >3 WU (determined at last right heart catheterization) b) Mean pulmonary arterial pressure (mPAP) =25 mmHg (determined at last right heart catheterization) c) Pulmonary arterial wedge pressure (PAWP) =15 mmHg (determined at last right heart catheterization) 3. Stable PAH background therapy for =3 months including endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE5) inhibitors, soluble guanylate cyclase (sGC) stimulators, prostacyclin analogues, prostacyclin-receptor agonists or any combination thereof 4. Scheduled for a control visit including right heart catherization 5. No morning intake of PAH background medication at the day of ularitide treatment 6. Negative pregnancy test (ß-human chorionic gonadotropin) at screening in women of childbearing age 7. Ability to understand the purpose and risks of the study and to provide signed and dated written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Known diagnosis of a) medium- or high-grade left-sided valvular disease b) hypertrophic obstructive cardiomyopathy c) chronic heart failure d) diastolic heart failure with preserved ejection fraction (HFpEF) e) state post pulmonary embolism f) clinically relevant parenchymal lung diseases as evidenced by - Ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC ratio) of 50 mmHg. 5. Uncontrolled severe systemic hypertension at screening, i.e. arterial hypertension >200 mmHg (systolic) or >120 mmHg (diastolic) 6. Estimated glomerular filtration rate (eGFR) 3 x upper limit of normal (ULN) or bilirubin >3 x ULN at screening 8. Use of sGC stimulators within three days prior to start of ularitide treatment 9. Use of nitric oxide donors or sacubitril-valsartan within three days prior to start of ularitide treatment 10. Known hypersensitivity to the active substance or to any of the excipients of the study drug or other natriuretic peptides 11. Known Hepatitis B or C or human immunodeficiency virus infection 12. Participation in an interventional clinical trial within one month prior to screening or 5 half-lives of the corresponding investigational medicinal product, whichever is longer 13. Active substance abuse 14. Legal incapacity or limited legal capacity 15. Breastfeeding or pregnancy 16. Employees of the sponsor or patients who are employees or relatives of the investigators 17. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To investigate the hemodynamic effects induced by step-wise increased doses of the IV administered natriuretic peptide ularitide in patients suffering from pulmonary arterial hypertension (PAH) - To investigate safety and tolerability of ularitide in patients suffering from PAH;Secondary Objective: Not applicable;Primary end point(s): Efficacy: Maximum absolute change of the PVR from baseline at the individual maximum tolerated ularitide dose. Safety: - Tolerability of ularitide (defined as number of patients with absence of stopping criteria) - Number of patients with premature treatment discontinuation due to safety reasons - Number of patients with a drop in SBP to values <90 mmHg (determined non-invasively) ;Timepoint(s) of evaluation of this end point: Primary efficacy and safety endpoints will be assessed after all patients have completed their treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Maximum relative change of the PVR from baseline at the individual maximum tolerated ularitide dose - Maximum absolute and relative change of PVR from baseline at each ularitide dose - Maximum absolute and relative change of SBP from baseline at each ularitide dose - Maximum absolute and relative change of diastolic blood pressure (DBP) from baseline at each ularitide dose - Maximum absolute and relative change of HR from baseline at each ularitide dose - Maximum absolute and relative change of peripheral oxygen saturation from baseline at each ularitide dose ;Timepoint(s) of evaluation of this end point: Secondary endpoints will be assessed after all patients have completed their treatment. | — |
Countries
Germany
Contacts
Public ContactCMO
Cardiorentis AG
Outcome results
None listed