Impact of Hypoxia on Resting and Exertional Right Ventricular Performance

NCT05272514 | Completed DMC

• 1 other identifier: 21-4354
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand how hypoxia (low oxygen) affects resting and exertional right ventricular function in healthy individuals.

Conditions

Ventricular Dysfunction, Right; Hypoxia

Outcome Measures

Primary Outcomes (2)

• Right ventricular contractility measured by conductance catheter

  End-systolic elastance (Ees) in mmHg/mL

  Up to 1 hour

• Right ventricular lusitropy (diastolic function) measured by conductance catheter

  Minimum dp/dt in mmHg/sec

  Up to 1 hour

Secondary Outcomes (7)

• Right ventricular stroke work measured by conductance catheter

  Up to 1 hour

• Mean pulmonary artery pressure measured by right heart catheterization

  Up to 1 hour

• Cardiac output derived from right heart catheterization

  Up to 1 hour

• Workload

  Up to 1 hour

• Maximal oxygen uptake

  Up to 1 hour

Study Arms (1)

Healthy individuals

10 healthy individuals will be recruited.

Other: Hypoxia

Interventions

Hypoxia OTHER

Individuals will be exposed to varying levels of hypoxia according to the protocol detailed above.

Healthy individuals

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

10 healthy men and women

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 (5)

• 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

• Forbes LM, Bull TM, Lahm T, Lawley JS, Hunter K, Levine BD, Lovering A, Roach RC, Subudhi AW, Cornwell WK 3rd. Right Ventricular Response to Acute Hypoxia among Healthy Humans. Am J Respir Crit Care Med. 2023 Aug 1;208(3):333-336. doi: 10.1164/rccm.202303-0599LE. No abstract available.

  PMID: 37311248 DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Right; Hypoxia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 9, 2022
• Study Start: April 15, 2022
• Primary Completion: August 30, 2022
• Study Completion: December 15, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)