Chronic Clinical Effect of Acetazolamide

Hypertension, Pulmonary Clinical Trial

— ChronicAZA  

Official title:

Chronic Clinical Effect of Acetazolamide in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755298
• Other study ID #: KEK-ZH-2016-00089-2
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2016
• Est. completion date: November 2020

Study information

• Verified date: December 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study seeks primarily to determine the chronic clinical effect of AZA on exercise capacity (6MWD) compared to placebo.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

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	Difference in 6 min walk distance	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	Difference of Quality of Life (QoL) assessed by the physical subscale of the living with pulmonary hypertension questionnaire (MLHF)	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	Progressive maximal ramp cardiopulmonary exercise testing	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	cerebral and muscle tissue oxygenation	At the end of both periods (AZA and Placebo) at rest and exercise	5 weeks
Secondary	daily activity	actigraphy	5 weeks
Secondary	morphological and functional parameters of the heart	measured by echocardiography	5 weeks
Secondary	New York Heart Association functional class	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	Short-form medical outcome questionnaire (SF-36)	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	N-terminal pro-brain natriuretic Peptide (NT-proBNP)	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	mean nocturnal oxygen Saturation during ambulatory sleep studies	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	apnea/hypopnea index during ambulatory sleep studies	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	Stroop test of cognitive performance	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	Trail making test (test of cognitive Performance)	At the end of both periods (AZA and Placebo)	5 weeks
Secondary	5 point test (test of cognitive Performance)	At the end of both periods (AZA and Placebo)	5 weeks