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

NCT05349630 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 21-4354b
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoxia; Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (2)

• Maximum workload

  Workload in Watts at peak exercise on upright cycle ergometer

  Up to 1 hour

• Maximal oxygen uptake

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

  Up to 1 hour

Secondary Outcomes (6)

• Oxygen saturation at peak exercise

  Up to 1 hour

• Submaximal Stage 1 workload

  Up to 1 hour

• Submaximal Stage 2 workload

  Up to 1 hour

• Ventilatory threshold

  Up to 1 hour

• Tricuspid annular plane systolic excursion measured by echocardiography

  Up to 1 hour

Study Arms (2)

Healthy individuals - pre-iron

PLACEBO COMPARATOR

Five 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).

Drug: Ferrous sulfate 325mg

Healthy individuals - post-iron

ACTIVE COMPARATOR

The same five healthy participants will complete echocardiography and exercise testing after taking 30 days of oral iron supplementation.

Drug: Ferrous sulfate 325mg

Interventions

Ferrous sulfate 325mg DRUG

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

Healthy individuals - post-iron; Healthy individuals - pre-iron

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 - 60
• For women, premenopausal status

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

• 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.

  PMID: 18955380 BACKGROUND

• 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.

  PMID: 19809026 BACKGROUND

• 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.

  PMID: 32347547 BACKGROUND

• 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.

  PMID: 34496612 BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, Right; Hypoxia

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

William Cornwell, MD

CONTACT

303-724-2085; william.cornwell@cuanschutz.edu

Lindsay Forbes, MD

CONTACT

lindsay.forbes@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start (Estimated): March 1, 2028
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)