A Study to Determine if Early Changes of Pulmonary Artery Hypertension can be Seen by Adding Exercise During Cardiac Magnetic Resonance Imaging (MRI)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 16-003749
Sponsor Protocol Number: 16-003749
About this study
The purpose of this study is to evaluate the diagnostic benefit of adding exercise to cardiac Magnetic Resonance Imaging to help show early changes that may assist in the earlier diagnosis of Pulmonary Artery Hypertension.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Consecutive patients aged ≥18 years with confirmed or high clinical suspicion for group 1 Pulmonary artery hypertension as dictated by a comprehensive examination and echocardiography
Exclusion Criteria
- Under 18 years of age
- Portopulmonary hypertension (i.e. PAH in the presence of chronic liver disease and confirmed portal hypertension)
- Pregnancy
- Mechanical ventilation
- Acute or chronic renal failure
- Creatinine clearance <30 ml/min
- Requires renal replacement therapy
- Inability to perform CMR (i.e. claustrophobia, severe obesity (>150 kg), device incompatible with CMR)
- Inability to exercise adequately as assessed by investigator
- Significant arrhythmia that precludes adequate ECG-gating for the CMR (i.e. atrial fibrillation with highly variable cycle lengths)
- Prior heart or lung transplantation,
- Left ventricular systolic ejection fraction < 50%
- Diastolic failure based on Framingham criteria for heart failure with preserved ejection fraction
- Significant left-sided valvular disease such as ≥ moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation
- Prior valve surgery
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Brian Shapiro, M.D., M.A. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available