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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 Lung Vascular Research
Information provided by (Responsible Party):
Medical University of Graz

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.


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Arterial Hypertension Drug: Benzbromarone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Effects of Benzbromaron on the Pulmonary Circulation
Study Start Date : October 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016


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.




Primary Outcome Measures :
  1. Pulmonary vascular resistance (Wood units) assessed by right heart catheterization [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790450


Locations
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Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Ludwig Boltzmann Institute Lung Vascular Research
Investigators
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Principal Investigator: Horst Olschewski, MD Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02790450    
Other Study ID Numbers: 27-253 ex 14/15
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Benzbromarone
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents