Chronic Clinical Effect of Acetazolamide (ChronicAZA)

University of Zurich (UZH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypertension, Pulmonary

Treatments: Drug: Acetazolamide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02755298

KEK-ZH-2016-00089-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Acetazolamide

Experimental group

Description:

Twice a day 250 mg acetazolamide for 5 weeks

Treatment:

Drug: Acetazolamide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo