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Chronic Clinical Effect of Acetazolamide (ChronicAZA)

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ClinicalTrials.gov Identifier: NCT02755298
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: Acetazolamide Drug: Placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Chronic Clinical Effect of Acetazolamide in Pulmonary Hypertension
Study Start Date : October 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetazolamide
Twice a day 250 mg acetazolamide for 5 weeks
Drug: Acetazolamide
Placebo Comparator: Placebo
Placebo capsule 250 mg (Mannitol) twice a day 5 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Difference in 6 min walk distance [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)


Secondary Outcome Measures :
  1. Difference of Quality of Life (QoL) assessed by the physical subscale of the living with pulmonary hypertension questionnaire (MLHF) [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  2. Progressive maximal ramp cardiopulmonary exercise testing [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  3. cerebral and muscle tissue oxygenation [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo) at rest and exercise

  4. daily activity [ Time Frame: 5 weeks ]
    actigraphy

  5. morphological and functional parameters of the heart [ Time Frame: 5 weeks ]
    measured by echocardiography

  6. New York Heart Association functional class [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  7. Short-form medical outcome questionnaire (SF-36) [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  8. Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  9. N-terminal pro-brain natriuretic Peptide (NT-proBNP) [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  10. mean nocturnal oxygen Saturation during ambulatory sleep studies [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  11. apnea/hypopnea index during ambulatory sleep studies [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  12. Stroop test of cognitive performance [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  13. Trail making test (test of cognitive Performance) [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)

  14. 5 point test (test of cognitive Performance) [ Time Frame: 5 weeks ]
    At the end of both periods (AZA and Placebo)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755298


Contacts
Contact: Silvia Ulrich, MD ++ 44 41 255 22 20 silvia.ulrich@usz.ch

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Silvia Ulrich, MD    0041442554362    silvia.ulrich@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Silvia Ulrich, MD UniversityHospital Zurich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02755298     History of Changes
Other Study ID Numbers: KEK-ZH-2016-00089-2
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Zurich:
Treatment Outcome
Acetazolamide

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs