Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With COPD Traveling to High Altitude

NCT04915365 | Unknown Phase 3

• 1 other identifier: 01-2021-SU-HAECHO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized, placebo-controlled double-blind trial is to evaluate the effect of acetazolamide on right heart function at rest in lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude (HA) and developing early signs of altitude-illness.

Conditions

Right Heart Function; Chronic Obstructive Pulmonary Disease; Altitude Sickness

Keywords

Acetazolamide; Mountain sickness; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Difference in change of pulmonary artery pressure

  Difference in change of pulmonary artery pressure (RV/RA) evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group

  3 days

Secondary Outcomes (6)

• Difference in change of pulmonary artery pressure (RV/RA) low altitude versus high altitude

  3 days

• Difference in cardiac output

  3 days

• Difference in right heart dimensions

  3 days

• Difference in right heart function

  3 days

• Difference in right heart function

  3 days

Study Arms (2)

Acetazolamide

EXPERIMENTAL

Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.

Drug: Acetazolamide

Placebo

PLACEBO COMPARATOR

Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.

Drug: Placebo

Interventions

Acetazolamide DRUG

Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.

Also known as: Acetazolamide, oral capsule

Acetazolamide

Placebo DRUG

Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.

Also known as: Placebo, oral capsule

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age 35-75 y, living at low altitude (\<800 m).
• COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, FEV1 40-80% predicted, pulse oximetry
• ≥92%, PaCO2 \<6 kPa, breathing ambient air at 760 m.
• One of the following early signs and/or symptoms of impending altitudeillness identified by self-monitoring during ascent to or stay at 3100 m:
• Pulse oximetry SpO2≤84%
• Headache or nausea/vomiting or fatigue/weakness or dizziness/lightheadedness of at least moderate intensity

You may not qualify if:

• COPD exacerbation, very severe COPD with hypoxemia or hypercapnia at 760 m (see above).
• Other lung disease, relevant comorbidities (such as uncontrolled cardiovascular disease, i.e., unstable arterial hypertension, coronary artery disease; previous stroke; obesity (body mass index \>35 kg/m2); internal, neurologic, rheumatologic or psychiatric disease; current heavy smoking (\>20 cigarettes per day).
• Renal failure and/or allergy to sulfonamides.
• Patients who do not have early signs and/or signs of impending altitudeillness by self-monitoring (as defined above) at 3'100m will not be included.

Sponsors & Collaborators

• University of Zurich: lead
• National Center of Cardiology and Internal Medicine, Kyrgyz Republic: collaborator

Study Sites (1)

National Center of Cardiology and Internal Medicine

Bishkek, 720040, Kyrgyzstan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Altitude Sickness; Hypertension, Pulmonary

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Silvia Ulrich, Prof

  University Hospital, Zürich, Switzerland

  STUDY CHAIR

• Talant M Sooronbaev, MD

  National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

  STUDY DIRECTOR

Central Study Contacts

Silvia Ulrich, Prof

CONTACT

+41442552220; silvia.ulrich@usz.ch

Konrad E. Bloch, Prof

CONTACT

+41442553828; konrad.bloch@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) An independent pharmacist will prepare identically looking active and placebo capsules labelled with secret codes. Codes will be concealed to investigators and patients until completion of data analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, placebo-controlled, double-blind

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 7, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KY (1)