Status:
NOT_YET_RECRUITING
Impact of Iron Supplementation on Right Ventricular Function and Exercise Performance in Hypoxia
Lead Sponsor:
University of Colorado, Denver
Conditions:
Right Ventricular Dysfunction
Hypoxia
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine if taking iron supplement pills improves exercise performance in low-oxygen conditions.
Detailed Description
Hypoxia (low oxygen) causes the blood vessels in the lungs to constrict (hypoxic pulmonary vasoconstriction). This increases the pressure (afterload) the right ventricle faces as it pumps blood to the...
Eligibility Criteria
Inclusion
- Age 18 - 60
- For women, premenopausal status
Exclusion
- Active cardiovascular or pulmonary disease (e.g. hypertension, coronary artery disease, cardiomyopathy, arrhythmia, valvular abnormalities, diabetes, peripheral vascular disease, tobacco use, chronic obstructive pulmonary disease, asthma, interstitial lung disease, restrictive lung disease, or pulmonary hypertension)
- Use of cardiac- or pulmonary-related medications
- Prior history of high altitude pulmonary edema or high altitude cerebral edema
- Body mass index \< 18.5 or \> 30
- Anemia
- Iron deficiency
- Iron supplementation (oral or intravenous) in the preceding 60 days
- Systemic anticoagulation or aspirin use that cannot be temporarily held for the study
- Pregnancy
- Non-cardiopulmonary disorders that adversely influence exercise ability (e.g. arthritis or peripheral vascular disease)
- Dedicated athletic training (defined here as spending \>9 hours per week in vigorous physical activity \[≥6 mets\])
- Regular high-altitude exercise (defined here as engaging in vigorous physical activity \[≥1 hour at ≥6 mets\] at ≥8,000 ft for \>2 days per week over the preceding 4 weeks)
- Residence at ≥8,000 ft for 3 or more consecutive nights in the preceding 30 days
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05349630
Start Date
March 1 2025
End Date
May 1 2026
Last Update
December 10 2024
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045