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Acute Effects of Benzbromaron on the Pulmonary Circulation

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ClinicalTrials.gov Identifier: NCT02790450
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : December 23, 2016
Sponsor:
Collaborator:
Ludwig Boltzmann Institute for Lung Vascular Research
Information provided by (Responsible Party):
Medical University of Graz

Tracking Information
First Submitted Date  ICMJE May 30, 2016
First Posted Date  ICMJE June 3, 2016
Last Update Posted Date December 23, 2016
Study Start Date  ICMJE October 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Pulmonary vascular resistance (Wood units) assessed by right heart catheterization [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2016)
Pulmonary vascular resistance [ Time Frame: 2 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Mean pulmonary arterial pressure (mmHg) assessed by right heart catheterization [ Time Frame: 2 hours ]
  • Mean systemic arterial pressure (mmHg) assessed by sphygmomanometer [ Time Frame: 2 hours ]
  • arterial oxygen saturation 8%) assessed by arterial blood gas analysis [ Time Frame: 2 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2016)
  • Mean pulmonary arterial pressure [ Time Frame: 2 hours ]
  • Mean systemic arterial pressure [ Time Frame: 2 hours ]
  • arterial oxygen saturation [ Time Frame: 2 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effects of Benzbromaron on the Pulmonary Circulation
Official Title  ICMJE Acute Effects of Benzbromaron on the Pulmonary Circulation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Arterial Hypertension
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Benzbromarone
1x200mg Benzbromarone
Intervention: Drug: Benzbromarone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02790450
Other Study ID Numbers  ICMJE 27-253 ex 14/15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE Ludwig Boltzmann Institute for Lung Vascular Research
Investigators  ICMJE
Principal Investigator: Horst Olschewski, MD Medical University of Graz
PRS Account Medical University of Graz
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP