The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension
Recruiting · NCT07824674 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
DextroseSildenafil 20mg
What this trial is about
The goal of this clinical study is to investigate whether the additional intake of sildenafil 20mg on top of standard medical treatment results in a benefit on maximum exercise workload (Wmax) in patients with pulmonary arterial hypertension (PAH).
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Signed Informed consent
- Age 18 - 80 years (both sexes)
- Pulmonary hypertension (PH) class I (PAH) previously diagnosed according to ESC/ERS 2022/2019 guidelines (mPAP ≥ 20 mmHg, PVR ≥ 2 WU, PAWP ≤ 15 mmHg) during diagnostic right-heart catheterization.
- Stable condition, on the same PH-medication for \>4 weeks
Exclusion criteria
- Severe resting hypoxia (PaO2 \<7.3 kPa)
- Moderate-to-severe chronic obstructive or restrictive pulmonary disease (FEV1 ≤ 60% predicted, FVC ≤ 60% predicted)
- Women with known pregnancy or breast feeding
- Other clinically significant concomitant disease states (e.g., severe renal or hepatic disease, unstable cardiovascular disease, etc.)
- Concurrent medication with:
- Nitric oxide donors (molsidomine, nicrorandil, etc.)
- Soluble guanylate cyclase stimulators (riociguat)
- Potent CYP3A4 inhibitors (azoles, clarithromycin, protease inhibitors)
- History of anterior ischemic optic neuropathy or hereditary retinal disease
- Participation in another study with investigational drug with potential influence the study data within the 30 days preceding and during the present study.
- Known allergies or hypersensitivity to sildenafil 20mg (Revatio 20mg) or dextrose candy (Dextroenergy) including any of its components
Where it is running
1 location listed.
- University Hospital of Zurich, Department of Pulmonology - Zurich, Canton of Zurich, Switzerland