search
Back to results

Acute Effects of Benzbromaron on the Pulmonary Circulation

Primary Purpose

Idiopathic Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Benzbromarone
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Benzbromarone

Arm Description

1x200mg Benzbromarone

Outcomes

Primary Outcome Measures

Pulmonary vascular resistance (Wood units) assessed by right heart catheterization

Secondary Outcome Measures

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

Full Information

First Posted
May 30, 2016
Last Updated
December 22, 2016
Sponsor
Medical University of Graz
Collaborators
Ludwig Boltzmann Institute for Lung Vascular Research
search

1. Study Identification

Unique Protocol Identification Number
NCT02790450
Brief Title
Acute Effects of Benzbromaron on the Pulmonary Circulation
Official Title
Acute Effects of Benzbromaron on the Pulmonary Circulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
Ludwig Boltzmann Institute for Lung Vascular Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benzbromarone
Arm Type
Experimental
Arm Description
1x200mg Benzbromarone
Intervention Type
Drug
Intervention Name(s)
Benzbromarone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary vascular resistance (Wood units) assessed by right heart catheterization
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Mean pulmonary arterial pressure (mmHg) assessed by right heart catheterization
Time Frame
2 hours
Title
Mean systemic arterial pressure (mmHg) assessed by sphygmomanometer
Time Frame
2 hours
Title
arterial oxygen saturation 8%) assessed by arterial blood gas analysis
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Olschewski, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Acute Effects of Benzbromaron on the Pulmonary Circulation

We'll reach out to this number within 24 hrs