Chronic Clinical Effect of Acetazolamide

University of Zurich24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension, Pulmonary

Interventions

AcetazolamideDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Difference in 6 min walk distance

At the end of both periods (AZA and Placebo)

Time frame: 5 weeks

Secondary Outcomes

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)

Time frame: 5 weeks

Progressive maximal ramp cardiopulmonary exercise testing

At the end of both periods (AZA and Placebo)

Time frame: 5 weeks

cerebral and muscle tissue oxygenation

At the end of both periods (AZA and Placebo) at rest and exercise

Time frame: 5 weeks

daily activity

actigraphy

Time frame: 5 weeks

morphological and functional parameters of the heart

measured by echocardiography

Time frame: 5 weeks

New York Heart Association functional class

At the end of both periods (AZA and Placebo)

Time frame: 5 weeks

Short-form medical outcome questionnaire (SF-36)

At the end of both periods (AZA and Placebo)

Time frame: 5 weeks

Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)

Data from ClinicalTrials.gov

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