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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03911856
Enrollment
7
Registered
2019-04-11
Start date
2020-01-09
Completion date
2024-01-16
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Disease

Brief summary

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

Interventions

OTHEREchocardiography

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.

OTHERPulmonary 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).

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in stroke volume (SV) during exercise and hyperoxia2 yearsStroke volume will be measured with echocardiography at rest and during exercise while breathing room air and hyperoxia
Change in oxygen uptake (VO2) during exercise and hyperoxia2 yearsOxygen uptake will be measured via pulmonary gas exchange at rest and during exercise while breathing room air and hyperoxia
Change in ventilatory efficiency (VE/VCO2) during exercise and hyperoxia2 yearsVentilatory effciency will be measured via pulmonary gas exchange at rest and during exercise while breathing room air and hyperoxia

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026