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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Disease
• Intervention / Treatment: Other: Echocardiography; Other: Pulmonary Gas Exchange

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-invasive assesment techniques; We hypothesize that non-invasive indices of right ventricular 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 pulmonary arterial hypertension and heart failure with preserved ejection fraction(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.	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.; Other: 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).
Experimental: Efficacy of acute-oxygen therapy during exercise; 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 pulse volume recording PVR, increasing RV functional reserve, increasing gas diffusion).	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.; Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bruce D Johnson, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): January 16, 2024
• Study Completion (Actual): January 16, 2024

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pulmonary Heart Disease
• Other Study ID Numbers: 19-000626

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No