Acute Effects of Benzbromaron on the Pulmonary Circulation

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Arterial Hypertension
• Interventions: Drug: Benzbromarone

• Registration Number: NCT02790450
• Lead Sponsor: Medical University of Graz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-05-30
• Study First Posted: 2016-06-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2016-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Benzbromarone	Benzbromarone	1x200mg Benzbromarone

Primary Outcome Measures

Name	Time	Method
Pulmonary vascular resistance (Wood units) assessed by right heart catheterization	2 hours

Secondary Outcome Measures

Name	Time	Method
Mean pulmonary arterial pressure (mmHg) assessed by right heart catheterization	2 hours
Mean systemic arterial pressure (mmHg) assessed by sphygmomanometer	2 hours
arterial oxygen saturation 8%) assessed by arterial blood gas analysis	2 hours

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria