Acute Effects of Benzbromaron on the Pulmonary Circulation

December 22, 2016 updated by: Medical University of Graz

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Benzbromarone
1x200mg Benzbromarone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary vascular resistance (Wood units) assessed by right heart catheterization
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Ludwig Boltzmann Institute for Lung Vascular Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

May 30, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27-253 ex 14/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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