Acute Effects of Benzbromaron on the Pulmonary Circulation

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Actual studies suggest that a calcium activated chlorid channel (TMEM16A) may play a relevant role in the pathogenesis of pulmonary arterial hypertension (PAH). The inhibition of this channel led to pulmonary vasorelaxation in preclinical studies. Benzbromarone is a well known inhibitor of the TMEM16A channel and is used in patients with gout.

In this pilot study the investigators plan to investigate if Benzbromarone has an acute effect on the pulmonary arteries in humans. This will be investigated within the frame of a right heart catheterization performed in patients with known PAH due to clinical reasons. The investigators hypothesize that the application of Benzbromarone leads to pulmonary vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. In addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge pressure, heart rate and arterial oxygen saturation will be assessed. Due to clinical reasons patients will receive NO (15 ppm) during right heart catheterization. Hemodynamic changes upon NO and Benzbromarone may be compared.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Collaborator: Ludwig Boltzmann Institute for Lung Vascular Research
• Treatments: Benzbromarone

Criteria

Inclusion Criteria:

• written informed consent

• known pulmonary arterial hypertension

• right heart catheterization indicated due to clinical reasons

Exclusion Criteria:

• known allergy against Benzbromaron, Gelborange S or other ingredient of the used drug (Benzbromarone AL) or a drug with similar chemical structure

• severe renal insufficiency (GFR<30ml/min/kg)

• renal diathesis

• severe hepatic disease (Bilirubin >1.6 mg% or AST or ALT > 3x Norm)

• known pregnancy

• uncontrolled systemic arterial hypertension (>150 mmHg systolic or 95 mmHg diastolic)

• uncontrolled ventricular arrythmia

• uncontrolled bradycardic or tachycardic supraventricular arrythmia

• myocardiac infarction within the last 12 months

• pulmonary embolism within the last 6 months

• ongoing iv. or sc. Prostanoid therapy for PAH

• Pulmonary hypertension other than PAH