← Back to Search

Diagnostic Exercise Testing for Cardiopulmonary Diseases

N/A

Waitlist Available

Led By Bruce D Johnson

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed PAH/HFpEF patients without any evidence of profound RV or pulmonary dysfunction

Healthy controls (no known cardiac or pulmonary disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new way to identify heart and lung problems earlier in people with cardiopulmonary diseases.

Who is the study for?

This trial is for healthy individuals and patients with early-stage heart failure or pulmonary arterial hypertension (PAH/HFpEF) who have not shown severe heart or lung dysfunction. It's not suitable for those unable to do light exercise or are pregnant/planning pregnancy.Check my eligibility

What is being tested?

The study aims to identify early signs of heart and lung imbalances in cardiopulmonary diseases using echocardiography (heart imaging) and tests that measure how the lungs exchange gases during exercise.See study design

What are the potential side effects?

There may be minimal side effects associated with this trial, primarily related to light exercise and non-invasive imaging procedures. However, specific risks will depend on individual health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am newly diagnosed with PAH/HFpEF and do not have severe heart or lung issues.

Select...

I do not have any known heart or lung diseases.

Select...

I have pulmonary arterial hypertension or heart failure with preserved ejection fraction and known lung issues.

Select...

I have right heart failure with PAH or HFpEF.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in oxygen uptake (VO2) during exercise and hyperoxia

Change in stroke volume (SV) during exercise and hyperoxia

Change in ventilatory efficiency (VE/VCO2) during exercise and hyperoxia

Trial Design

2Treatment groups

Experimental Treatment

Group I: Non-invasive assesment techniquesExperimental Treatment2 Interventions

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.

Group II: Efficacy of acute-oxygen therapy during exerciseExperimental Treatment2 Interventions

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).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,130 Total Patients Enrolled

Bruce D JohnsonPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

86 Total Patients Enrolled

Media Library

Echocardiography Clinical Trial Eligibility Overview. Trial Name: NCT03911856 — N/A

Cardiopulmonary Diseases Research Study Groups: Non-invasive assesment techniques, Efficacy of acute-oxygen therapy during exercise

Cardiopulmonary Diseases Clinical Trial 2023: Echocardiography Highlights & Side Effects. Trial Name: NCT03911856 — N/A

Echocardiography 2023 Treatment Timeline for Medical Study. Trial Name: NCT03911856 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of advanced age eligible to take part in this research project?

"The requirements for participants in this medical trial are that they be no younger than 18 and not exceed the age of 80."

Answered by AI

Is there an opportunity to volunteer for this clinical experiment?

"This trial is taking applications from 48 individuals with cardiovascular and pulmonary illnesses, ranging in age between 18 to 80. The acceptability criteria are as follows: Healthy controls (without cardiac or respiratory conditions); PAH/HFpEF patients experiencing RV insufficiency; PAH/HFpEF sufferers contending with impaired lung function; Recently diagnosed PAH/HFpEF patients who have not encountered extreme RV or respiratory difficulties."

Answered by AI

Are there any enrolment opportunities remaining for this investigation?

"Affirmative. The details on clinicaltrials.gov verify that this medical study, which was initiated on the 9th of January 2020, is presently looking for participants. 48 individuals from 1 site are required to participate in the trial."

Answered by AI

How many participants are being treated in this experiment?

"Affirmative. Clinicaltrials.gov has evidence that this experiment, which was originally posted on September 1st 2020, is actively enrolling participants. Approximately 48 individuals are being sought to join the trial at a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Bruce Johnson 2020. "Unmasking Right Ventricular and Pulmonary Derangements With Exercise and Oxygen in Early Stage Cardiopulmonary Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03911856.