Hypertension, Pulmonary
Conditions
Keywords
PAH, CTEPH, pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension
Brief summary
In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure in the pulmonary blood vessels due to Pulmonary Arterial Hypertension (PAH) and due to Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Pulmonary hypertension is characterized by the elevation of pressure in the pulmonary arteries (PAP) and of the pulmonary vascular resistance (PVR) leading to increased workload of the right chamber of the heart to eject blood against this elevated resistance. The goal of this study is to measure the safety and tolerability of the drug as well as the reduction of the PVR at different doses In Part A patients without specific treatment for PH (untreated patients) will be tested. In Part B also patients stably pre-treated with specific PH drugs will be studied in combination with the new inhaled drug
Interventions
DRUGBAY1237592
Oral inhalation with dry powder inhaler, single dose.
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Patients with PAH or CTEPH undergoing medically indicated routine invasive diagnostics * Men and women aged 18 to 80 years Part A: \- Untreated patients: Therapy-naïve patients (defined as off treatment with PDE-5 inhibitors, endothelin receptor antagonists, prostanoids, or other sGC stimulators/activators) with PAH or CTEPH or patients pre-treated with these medications who have to undergo a drug specific wash-out period at the discretion of the investigator for least 24 h prior to Day -1 if medically safe Part B: * Untreated patients with PAH or CTEPH: \-- Group 1 (total will be summed up with corresponding dosage group from Part A) * Pre-treated patients with PAH or CTEPH: * Group 2: Pre-treated patients with any kind of monotherapy\* for PAH/CTEPH * Group 3: Pre-treated patients with any kind of double combination therapy\* for PAH/CTEPH \* patients receiving inhaled Iloprost, and patients who are known responders to iNO are excluded Main
Exclusion criteria
\- Medical history indicating a different cause for PH than PAH or CTEPH according to the guidelines of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), such as significant left heart disease, valvular disease, or structural heart defects, as assessed by the investigator, significant pulmonary disease or clinical suspicion of pulmonary venoocclusive disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak percent reduction in PVR (Pulmonary vascular resistance) from baseline 2 for untreated patients | Up to 5 hours post inhalation of BAY1237592 compared to baseline 2 | PVR = 80\* (PAP - PCWP) / CO (dyn·sec·cm-5) * PAP = pulmonary arterial pressure * PCWP = pulmonary capillary wedge pressure * CO = cardiac output |
| Peak percent reduction in PVR from baseline for pre-treated patients | Up to 5 hours post inhalation of BAY1237592 compared to baseline | PVR = 80\* (PAP - PCWP) / CO (dyn·sec·cm-5) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 7 days after treatment |
Countries
Austria, Czechia, Germany, Poland
Outcome results
None listed