Effect of Acetazolamide on Right Ventricular Function During Exercise in Patients With Respiratory Disease at Altitude
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03167034
- Lead Sponsor
- University of Zurich
- Brief Summary
This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function during exercise at acute altitude exposure in patients with COPD.
- Detailed Description
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function during exercise in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.
Right ventricular function will be assessed during graded cycling on an ergometer by transthoracic echocardiography.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- Male and female patients, age 18-75 yrs.
- COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
- Born, raised and currently living at low altitude (<800m).
- Written informed consent.
- COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92% at 750 m).
- Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
- Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (>20 cigarettes per day)
- Known renal failure or allergy to acetazolamide and other sulfonamides
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACETAZOLAMIDE oral capsule ACETAZOLAMIDE oral capsule Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m PLACEBO oral capsule Placebo oral capsule Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m.
- Primary Outcome Measures
Name Time Method pulmonary artery pressure during exercise Day 2 at 3200m Difference in change of tricuspid pressure gradient during exercise between acetazolamide and placebo group at altitude, measured by transthoracic echocardiography during graded cycling on an ergometer
- Secondary Outcome Measures
Name Time Method pulmonary artery pressure during exercise Day 2 at 760 m and 3200 m Difference in altitude-induced change of tricuspid pressure gradient during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer
Oxygen saturation Day 2 at 760 m and 3200 m Difference in change of oxygen saturation during exercise between acetazolamide and placebo group, measured by pulse oximeter
cardiac output during exercise Day 2 at 760 m and 3200 m Difference in altitude-induced change of cardiac output during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer
PAP/CO slope during exercise Day 2 at 760 m and 3200 m Difference in altitude-induced change of PAP/CO slope during exercise between acetazolamide and placebo group, measured by transthoracic echocardiography during graded cycling on an ergometer
Trial Locations
- Locations (1)
National Center for Cardiology and Internal Medicine
🇰🇬Bishkek, Kyrgyzstan