Back to resultsUnmasking Right Ventricular and Pulmonary Derangements With Exercise and Oxygen in Early Stage Cardiopulmonary Diseases
Primary Purpose
Cardiopulmonary Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Echocardiography
Pulmonary Gas Exchange
Sponsored by
About this trial
This is an interventional other trial for Cardiopulmonary Disease
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Non-invasive assesment techniques
Efficacy of acute-oxygen therapy during exercise
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03911856
Brief Title
Unmasking Right Ventricular and Pulmonary Derangements With Exercise and Oxygen in Early Stage Cardiopulmonary Diseases
Official Title
Unmasking Right Ventricular and Pulmonary Derangements With Exercise and Oxygen in Early Stage Cardiopulmonary Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to develop innovative strategies that target the early identification heart and lung imbalances in patients with cardiopulmonary diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-invasive assesment techniques
Arm Type
Experimental
Arm Description
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.
Arm Title
Efficacy of acute-oxygen therapy during exercise
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Echocardiography
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pulmonary Gas Exchange
Intervention Description
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 Outcome Measure Information:
Title
Change in stroke volume (SV) during exercise and hyperoxia
Description
Stroke volume will be measured with echocardiography at rest and during exercise while breathing room air and hyperoxia
Time Frame
2 years
Title
Change in oxygen uptake (VO2) during exercise and hyperoxia
Description
Oxygen uptake will be measured via pulmonary gas exchange at rest and during exercise while breathing room air and hyperoxia
Time Frame
2 years
Title
Change in ventilatory efficiency (VE/VCO2) during exercise and hyperoxia
Description
Ventilatory effciency will be measured via pulmonary gas exchange at rest and during exercise while breathing room air and hyperoxia
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce D Johnson
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glenn Stewart
Phone
507-538-4890
Email
stewart.glenn@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Unmasking Right Ventricular and Pulmonary Derangements With Exercise and Oxygen in Early Stage Cardiopulmonary Diseases
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