AcuteAZA: Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension
Study Details
Study Description
Brief Summary
To study the acute effect of acetazolamide (AZA) on pulmonary hemodynamics in patients with pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation (RHC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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. The investigators 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 acute hemodynamic clinical effects of AZA in PH patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acetazolamide Diamox 500mg i.v. (1x) |
Drug: Acetazolamide
|
| Placebo Comparator: Placebo Placebo Saline injection (1x) |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Pulmonary vascular resistance (PVR) AZA vs. Placebo (rest) [60 minutes]
At the end of phase at rest
- PVR AZA vs. Placebo (exercise) [60 minutes]
At the end of phase at exercise
- PVR AZA vs. Placebo (hypoxia) [60 minutes]
At the end of phase under hypoxia
Secondary Outcome Measures
- partial pressure of the oxygen [60 minutes]
At the end of each phase (rest, exercise and hypoxia)
- Oxygen uptake [15 minutes]
- minute ventilation [15 minutes]
- arterial oxygenation [60 minutes]
At the end of each phase (rest, exercise and hypoxia)
- tissue oxygenation [60 minutes]
At the end of each phase (rest, exercise and hypoxia)
- mean pulmonary arterial pressure [60 minutes]
At the end of each phase (rest, exercise and hypoxia)
- cardiac output [60 minutes]
At the end of each phase (rest, exercise and hypoxia)
- cardiac index [60 minutes]
At the end of each phase (rest, exercise and hypoxia)
- pulmonary wedge pressure [60 minutes]
At the end of each phase (rest, exercise and hypoxia)
- Borg scale dyspnea and leg effort [15 minutes]
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients undergoing RHC for a clinical indication and who are diagnosed with precapillary PH (mPAP ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Zurich | Zurich | Switzerland | 8091 |
Sponsors and Collaborators
- University of Zurich
Investigators
- Principal Investigator: Silvia Ulrich, MD, UniversityHospital Zurich
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KEK-ZH-2016-00089