Acute Effects of Benzbromaron on the Pulmonary Circulation

Idiopathic Pulmonary Arterial Hypertension Clinical Trial

Official title:

Acute Effects of Benzbromaron on the Pulmonary Circulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790450
• Other study ID #: 27-253 ex 14/15
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2016
• Last updated: December 22, 2016
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Idiopathic Pulmonary Arterial Hypertension

Intervention

Drug:
• Benzbromarone
1x200mg Benzbromarone will be applied after baseline measurements during right heart catheterization. The effects of the drug on the pulmonary hemodynamics will be assessed after 2 hours.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Ludwig Boltzmann Institute for Lung Vascular Research

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary vascular resistance (Wood units) assessed by right heart catheterization		2 hours	No
Secondary	Mean pulmonary arterial pressure (mmHg) assessed by right heart catheterization		2 hours	No
Secondary	Mean systemic arterial pressure (mmHg) assessed by sphygmomanometer		2 hours	Yes
Secondary	arterial oxygen saturation 8%) assessed by arterial blood gas analysis		2 hours	Yes