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The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension

RecruitingPhase 2, Phase 3Ages 18 Years - 80 YearsAllSilvia Ulrich
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 20 mmHg, PVR โ‰ฅ 2 WU, PAWP โ‰ค 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 โ‰ค 60% predicted, FVC โ‰ค 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
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What it tests

  • Dextrose
  • Sildenafil 20mg
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Where

1 site
University Hospital of Zurich, Department of Pulmonology
Zurich, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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