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OpenTrials
Completed

NCT Number: NCT03911856

Unmasking Right Ventricular and Pulmonary Derangements With Exercise and Oxygen in Early Stage Cardiopulmonary Diseases

Researchers are trying to develop innovative strategies that target the early identification heart and lung imbalances in patients with cardiopulmonary diseases.

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Key information

Conditions

Cardiopulmonary Disease Cardiovascular Diseases Heart Diseases Pulmonary Heart Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy controls (no known cardiac or pulmonary disease);
  • PAH/HFpEF patients with known RV failure;
  • PAH/HFpEF patients with known pulmonary failure
  • Newly diagnosed PAH/HFpEF patients without any evidence of profound RV or pulmonary dysfunction.

Exclusion criteria

  • Persons unable to perform light exercise
  • Persons pregnant or planning to be pregnant

Treatment and study plan

echocardiography

Other

We hypothesize that non-invasive indices of RV (echocardiograph-derived strain and strain rate) and pulmonary (gas exchange-derived lung diffusion and surface area) function during light exercise will successfully identify and discern patients with known RV dysfunction (PAH/HFpEF with RV failure) from those with known pulmonary dysfunction (PAH/HFpEF with pulmonary fibrosis). Additionally, we hypothesize that our assessment techniques will identify subtle derangements in RV and pulmonary function in newly diagnosed PAH and HFpEF patients, and that this may guide early and targeted therapeutic intervention.

Pulmonary Gas Exchange

Other

We hypothesize that breathing hyperoxia will increase exercise capacity by reversing RV and pulmonary derangements, and that the mechanisms of action will be related to the underlying dysfunction (e.g., reducing PVR, increasing RV functional reserve, increasing gas diffusion).

Primary outcomes

  1. Change in stroke volume (SV) during exercise and hyperoxia

    Time frame: 2 years

    Stroke volume will be measured with echocardiography at rest and during exercise while breathing room air and hyperoxia

  2. Change in oxygen uptake (VO2) during exercise and hyperoxia

    Time frame: 2 years

    Oxygen uptake will be measured via pulmonary gas exchange at rest and during exercise while breathing room air and hyperoxia

  3. Change in ventilatory efficiency (VE/VCO2) during exercise and hyperoxia

    Time frame: 2 years

    Ventilatory effciency will be measured via pulmonary gas exchange at rest and during exercise while breathing room air and hyperoxia

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2019
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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