Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension

Hypertension, Pulmonary Clinical Trial

— AcuteAZA  

Official title:

Acute Hemodynamic Effect of Acetazolamide in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755259
• Other study ID #: KEK-ZH-2016-00089
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: August 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Acetazolamide

• Placebo

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary vascular resistance (PVR) AZA vs. Placebo (rest)	At the end of phase at rest	60 minutes
Primary	PVR AZA vs. Placebo (exercise)	At the end of phase at exercise	60 minutes
Primary	PVR AZA vs. Placebo (hypoxia)	At the end of phase under hypoxia	60 minutes
Secondary	partial pressure of the oxygen	At the end of each phase (rest, exercise and hypoxia)	60 minutes
Secondary	Oxygen uptake		15 minutes
Secondary	minute ventilation		15 minutes
Secondary	arterial oxygenation	At the end of each phase (rest, exercise and hypoxia)	60 minutes
Secondary	tissue oxygenation	At the end of each phase (rest, exercise and hypoxia)	60 minutes
Secondary	mean pulmonary arterial pressure	At the end of each phase (rest, exercise and hypoxia)	60 minutes
Secondary	cardiac output	At the end of each phase (rest, exercise and hypoxia)	60 minutes
Secondary	cardiac index	At the end of each phase (rest, exercise and hypoxia)	60 minutes
Secondary	pulmonary wedge pressure	At the end of each phase (rest, exercise and hypoxia)	60 minutes
Secondary	Borg scale dyspnea and leg effort		15 minutes