AzTrials
AzTrials

Right Ventricular DysfunctionEarly Phase 1NCT05349630

Impact of Iron Supplementation on Right Ventricular Function and Exercise Performance in Hypoxia

A Early Phase 1 study testing Ferrous sulfate 325mg in people with Right Ventricular Dysfunction and Hypoxia, run by University of Colorado, Denver at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to determine if taking iron supplement pills improves exercise performance in low-oxygen conditions. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Right Ventricular Dysfunction, Hypoxia
What is being tested?
Ferrous sulfate 325mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
1 siteUnited States
Study dates
Mar 2028to May 2030
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18 - 60
  • For women, premenopausal status

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

William Cornwell, MD contact

303-724-2085

william.cornwell@cuanschutz.edu

Lindsay Forbes, MD contact

lindsay.forbes@cuanschutz.edu

United States1 site

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    William Cornwell, MD, 303-724-2085, william.cornwell@cuanschutz.edu

    Lindsay Forbes, MD, lindsay.forbes@cuanschutz.edu

Other trials in United States

About this study

Official title: Impact of Iron Supplementation on Right Ventricular Function and Exercise Performance in Hypoxia (A Sub-Study)

The purpose of this study is to determine if taking iron supplement pills improves exercise performance in low-oxygen conditions.

Read the 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 lungs. Increased right ventricular afterload during hypoxia may compromise exercise capacity. Intravenous iron administration prior to hypoxic exposure has been shown to blunt the hypoxia-induced increase in right ventricular afterload. This may be through iron's action in the Hypoxia Inducible Factor (HIF) pathway. Iron is a cofactor for prolyl hydroxylases that degrade HIF subunits and thus may "turn off" HIF-related pathways of pulmonary artery vasoconstriction and remodeling. However, it is not known whether oral iron supplementation similarly reduces right ventricular afterload in hypoxia, or what impact iron has on right ventricular function and exercise capacity in hypoxia.

This is a human physiology study that will characterize the impact of oral iron supplementation on right ventricular function and exercise performance in hypoxia. It is a follow-up "sub-study" to a separate, "parent" study (NCT05272514) by the same investigators which evaluates resting and exertional right ventricular performance in normoxia and hypoxia in 10 healthy individuals. In this follow-up study, 5 individuals who completed the parent study will be eligible to enroll. As part of the parent study, participants will complete baseline echocardiography to assess right ventricular function and cardiopulmonary exercise testing to assess exercise performance in normoxia and hypoxia. After enrolling in this study, participants will take an oral iron supplement (ferrous sulfate 325 mg oral daily) for 30 days. They will then return for one visit. First, participants will complete submaximal exercise while breathing room air. Submaximal exercise will include 5 minutes each at 40% and 60% of baseline hypoxic (fraction of inspired oxygen [FiO2] 12%) maximal oxygen uptake (VO2max) achieved during parent study. After 10 minutes' rest, echocardiographic measurements will be obtained at upright rest with FiO2 21%, 17%, 15%, and 12% to characterize the impact of progressive hypoxia on resting right ventricular function. Participants will then repeat submaximal exercise tests at FiO2 12%, followed by a short period of recovery. Thereafter, participants will complete a symptom-limited cardiopulmonary exercise test at FiO2 12%. Measurements will include heart rate/rhythm, oxygen saturation, blood pressure, gas exchange parameters (oxygen uptake [VO2], carbon dioxide production [VCO2], and minute ventilation), rated perceived exertion and resting echocardiographic measurements.

Being tested
Ferrous sulfate 325mg
Medical subject headings
Ventricular Dysfunction, Right, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferrous sulfate 325mgDrug

    Participants will take one tab of ferrous sulfate 325 mg (equivalent to 65 mg elemental iron) daily for 30 days.

Study groups in NCT05349630
Study groupRoleWhat they receive
Healthy individuals - pre-ironPlacebo comparatorFive healthy participants will be enrolled. Baseline echocardiography and exercise data prior to oral iron supplementation will be obtained as part of the "parent" study to this study (NCT05272514).
Receives: Drug: Ferrous sulfate 325mg
Healthy individuals - post-ironActive comparatorThe same five healthy participants will complete echocardiography and exercise testing after taking 30 days of oral iron supplementation.
Receives: Drug: Ferrous sulfate 325mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum workload

    Workload in Watts at peak exercise on upright cycle ergometer

    Measured: Up to 1 hour

  2. Maximal oxygen uptake

    Maximal oxygen uptake at peak exercise (VO2max) in L/min

    Measured: Up to 1 hour

Secondary outcomes (6)

  1. Oxygen saturation at peak exercise

    Peripheral oxygen saturation (SpO2)

    Measured: Up to 1 hour

  2. Submaximal Stage 1 workload

    Workload in Watts at 40% x hypoxic VO2max (obtained during baseline hypoxic exercise test)

    Measured: Up to 1 hour

  3. Submaximal Stage 2 workload

    Workload in Watts at 60% x hypoxic VO2max (obtained during baseline hypoxic exercise test)

    Measured: Up to 1 hour

  4. Ventilatory threshold

    Oxygen uptake (VO2 in L/min) at which slope of VCO2/VO2 relationship increases

    Measured: Up to 1 hour

  5. Tricuspid annular plane systolic excursion measured by echocardiography

    In mm

    Measured: Up to 1 hour

  6. Pulmonary artery systolic pressure measured by echocardiography

    In mmHg

    Measured: Up to 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2022
  2. Study startMar 2028 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Model description
All participants will complete resting echocardiography and exercise testing as part of parent study prior to oral iron supplementation. Participants who enroll in this study will complete 30 days of oral iron supplementation and then repeat resting echocardiography and exercise testing.
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05349630
Sponsor's protocol ID
21-4354b
Status last verified
Apr 2026
First submitted
21 Apr 2022
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smith TG, Balanos GM, Croft QP, Talbot NP, Dorrington KL, Ratcliffe PJ, Robbins PA. The increase in pulmonary arterial pressure caused by hypoxia depends on iron status. J Physiol. 2008 Dec 15;586(24):5999-6005. doi: 10.1113/jphysiol.2008.160960. Epub 2008 Oct 27.

    PubMed 18955380

  • Smith TG, Talbot NP, Privat C, Rivera-Ch M, Nickol AH, Ratcliffe PJ, Dorrington KL, Leon-Velarde F, Robbins PA. Effects of iron supplementation and depletion on hypoxic pulmonary hypertension: two randomized controlled trials. JAMA. 2009 Oct 7;302(13):1444-50. doi: 10.1001/jama.2009.1404.

    PubMed 19809026

  • Cornwell WK, Tran T, Cerbin L, Coe G, Muralidhar A, Hunter K, Altman N, Ambardekar AV, Tompkins C, Zipse M, Schulte M, O'Gean K, Ostertag M, Hoffman J, Pal JD, Lawley JS, Levine BD, Wolfel E, Kohrt WM, Buttrick P. New insights into resting and exertional right ventricular performance in the healthy heart through real-time pressure-volume analysis. J Physiol. 2020 Jul;598(13):2575-2587. doi: 10.1113/JP279759. Epub 2020 May 18.

    PubMed 32347547

  • Cornwell WK 3rd, Baggish AL, Bhatta YKD, Brosnan MJ, Dehnert C, Guseh JS, Hammer D, Levine BD, Parati G, Wolfel EE; American Heart Association Exercise, Cardiac Rehabilitation, and Secondary Prevention Committee of the Council on Clinical Cardiology; and Council on Arteriosclerosis, Thrombosis and Vascular Biology. Clinical Implications for Exercise at Altitude Among Individuals With Cardiovascular Disease: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2021 Oct 5;10(19):e023225. doi: 10.1161/JAHA.121.023225. Epub 2021 Sep 9.

    PubMed 34496612

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ferrous sulfate 325mg in people with Right Ventricular Dysfunction and Hypoxia, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact William Cornwell, MD (303-724-2085, william.cornwell@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum workload (time frame: Up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05349630, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in