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

Cardiopulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911856
• Other study ID #: 19-000626
• Status: Completed
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: January 16, 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 16, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Disease
• Pulmonary Heart Disease

Intervention

Other:
• Echocardiography
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
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).

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stroke volume (SV) during exercise and hyperoxia	Stroke volume will be measured with echocardiography at rest and during exercise while breathing room air and hyperoxia	2 years
Primary	Change in oxygen uptake (VO2) during exercise and hyperoxia	Oxygen uptake will be measured via pulmonary gas exchange at rest and during exercise while breathing room air and hyperoxia	2 years
Primary	Change in ventilatory efficiency (VE/VCO2) during exercise and hyperoxia	Ventilatory effciency will be measured via pulmonary gas exchange at rest and during exercise while breathing room air and hyperoxia	2 years