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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Pulmonary vascular resistance (Wood units) assessed by right heart catheterization [ Time Frame: 2 hours ]
- 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 ]
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
|Medical University of Graz|
|Graz, Austria, 8036|
|Principal Investigator:||Horst Olschewski, MD||Medical University of Graz|