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

NCT03911856 | Completed

• 1 other identifier: 19-000626
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiopulmonary Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Non-invasive assesment techniques

EXPERIMENTAL

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; Other: Pulmonary Gas Exchange

Efficacy of acute-oxygen therapy during exercise

EXPERIMENTAL

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; Other: Pulmonary Gas Exchange

Interventions

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.

Efficacy of acute-oxygen therapy during exercise; Non-invasive assesment techniques

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).

Efficacy of acute-oxygen therapy during exercise; Non-invasive assesment techniques

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pulmonary Heart Disease

Interventions

Pulmonary Gas Exchange

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Transport; Biological Transport; Metabolism; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Bruce D Johnson

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 11, 2019
• Study Start: January 9, 2020
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

US (1)