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Acute Effects of Benzbromaron on the Pulmonary Circulation

NCT ID: NCT02790450

Last Updated: 2016-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Idiopathic Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Benzbromarone

1x200mg Benzbromarone

Group Type EXPERIMENTAL

Benzbromarone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig Boltzmann Institute for Lung Vascular Research

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horst Olschewski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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27-253 ex 14/15

Identifier Type: -

Identifier Source: org_study_id