Chronic Clinical Effect of Acetazolamide

NCT ID: NCT02755298

Last Updated: 2020-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-11-30

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.

Conditions

Hypertension, Pulmonary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acetazolamide

Twice a day 250 mg acetazolamide for 5 weeks

Group Type: EXPERIMENTAL

Acetazolamide

Intervention Type: DRUG

Placebo

Placebo capsule 250 mg (Mannitol) twice a day 5 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Acetazolamide

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Ulrich, MD

Role: PRINCIPAL_INVESTIGATOR

UniversityHospital Zurich

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

Lichtblau M, Saxer S, Muller J, Appenzeller P, Berlier C, Schneider SR, Mayer L, Furian M, Schwarz EI, Swenson ER, Bloch KE, Ulrich S. Effect of 5 weeks of oral acetazolamide on patients with pulmonary vascular disease: A randomized, double-blind, cross-over trial. Pulmonology. 2024 Jul-Aug;30(4):362-369. doi: 10.1016/j.pulmoe.2022.11.004. Epub 2023 Jan 11.

Reference Type: DERIVED

PMID: 36639329 (View on PubMed)

Other Identifiers

KEK-ZH-2016-00089-2

Identifier Type: -

Identifier Source: org_study_id