Chronic Clinical Effect of Acetazolamide
- Registration Number
- NCT02755298
- Lead Sponsor
- University of Zurich
- Brief Summary
The study seeks primarily to determine the chronic clinical effect of AZA on exercise capacity (6MWD) compared to placebo.
- Detailed Description
Pulmonary hypertension (PH) of various etiologies causes dyspnea, impairs exercise performance and is associated with reduced quality of life (QoL) and survival. Treatment options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and, in selected cases, pulmonary endarterectomy or lung transplantation. Unfortunately, PH specific drugs are expensive, associated with side effects and even combined pharmacological treatment is often not sufficient to achieve clinical benefits. Therefore, novel therapeutic drugs are needed. We have recently demonstrated that sleep related breathing disorders, which are common in PH patients, can be improved by both nocturnal oxygen therapy and acetazolamide (AZA). AZA is a carbonic anhydrase (CA) inhibitor that acts as a respiratory stimulant thereby improving oxygenation and possibly PH. There are even data suggesting that CA-inhibitors have a direct pulmonary vasodilator effect. However, the potential role of AZA in the treatment of PH has not been conclusively studied. Therefore, the purpose of the current project is to investigate, the chronic clinical effects of AZA in PH patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- All patients undergoing right heart catheterisation (RHC) for a clinical indication and who are diagnosed with precapillary PH (mean pulmonary arterial pressure (mPAP) ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
- Patients have to be in a stable condition, on the same medication for >4 weeks
- Patients in whom a RHC is clinically not indicated
- pregnant women
- PH in left heart disease or with more than mild chronic obstructive pulmonary disease or restrictive lung disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Acetazolamide Acetazolamide Twice a day 250 mg acetazolamide for 5 weeks Placebo Placebo Placebo capsule 250 mg (Mannitol) twice a day 5 weeks
- Primary Outcome Measures
Name Time Method Difference in 6 min walk distance 5 weeks At the end of both periods (AZA and Placebo)
- Secondary Outcome Measures
Name Time Method daily activity 5 weeks actigraphy
Progressive maximal ramp cardiopulmonary exercise testing 5 weeks At the end of both periods (AZA and Placebo)
morphological and functional parameters of the heart 5 weeks measured by echocardiography
Trail making test (test of cognitive Performance) 5 weeks At the end of both periods (AZA and Placebo)
cerebral and muscle tissue oxygenation 5 weeks At the end of both periods (AZA and Placebo) at rest and exercise
New York Heart Association functional class 5 weeks At the end of both periods (AZA and Placebo)
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) 5 weeks At the end of both periods (AZA and Placebo)
mean nocturnal oxygen Saturation during ambulatory sleep studies 5 weeks At the end of both periods (AZA and Placebo)
Difference of Quality of Life (QoL) assessed by the physical subscale of the living with pulmonary hypertension questionnaire (MLHF) 5 weeks At the end of both periods (AZA and Placebo)
Short-form medical outcome questionnaire (SF-36) 5 weeks At the end of both periods (AZA and Placebo)
N-terminal pro-brain natriuretic Peptide (NT-proBNP) 5 weeks At the end of both periods (AZA and Placebo)
apnea/hypopnea index during ambulatory sleep studies 5 weeks At the end of both periods (AZA and Placebo)
Stroop test of cognitive performance 5 weeks At the end of both periods (AZA and Placebo)
5 point test (test of cognitive Performance) 5 weeks At the end of both periods (AZA and Placebo)
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zurich, Switzerland