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CompletedNCT02790450Updated Dec 23, 2016

Acute Effects of Benzbromaron on the Pulmonary Circulation

A Phase 2 interventional study of Benzbromarone in Idiopathic Pulmonary Arterial Hypertension, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-12-23.

Sponsored by Medical University of Graz · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

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Conditions studied

  • Idiopathic Pulmonary Arterial Hypertension
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 10 is below the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • written informed consent
  • known pulmonary arterial hypertension
  • right heart catheterization indicated due to clinical reasons

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Benzbromarone

    1x200mg Benzbromarone

    Drug: Benzbromarone

Interventions

  • DrugBenzbromarone

    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.

06

What researchers measure

Primary outcomes

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

    Time frame: 2 hours

Secondary outcomes

  1. Mean pulmonary arterial pressure (mmHg) assessed by right heart catheterization

    Time frame: 2 hours

  2. Mean systemic arterial pressure (mmHg) assessed by sphygmomanometer

    Time frame: 2 hours

  3. arterial oxygen saturation 8%) assessed by arterial blood gas analysis

    Time frame: 2 hours

07

Study locations

1 site
  • Medical University of Graz
    Graz, 8036, Austria
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02790450
Lead sponsor
Medical University of Graz
Collaborators
Ludwig Boltzmann Institute for Lung Vascular Research
Responsible party
Sponsor
First posted
Jun 3, 2016
Start date
Oct 2015
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Dec 23, 2016

Study contacts

Horst Olschewski, MD
principal investigator · Medical University of Graz

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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