Heart Failure Patients Ventilatory Constraint During Exercise
Overview
Tab Title Description
Study type
ObservationalDescribes 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
- Rochester, Minnesota: 23-004881
About this study
The purpose of this study is to characterize the ventilatory response to exercise in females with HFrEF and determine if mechanical ventilatory constraint occurs during exercise. Also, to determine if ventilatory constraint affects exercise tolerance in patients with HFrEF, by alleviating mechanical ventilatory constraint via a helium (He) backed inspirate during exercise.
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:
- Age ≥ 18 years.
- Confirmed diagnosis of ischemic or dilated cardiomyopathy with symptoms > 1 year.
- Left-ventricular ejection fraction < 40%:
- Measured within 12 months.
- Stable heart failure symptoms for ≥ 3 months
- No change in medication in last 6 weeks.
Exclusion Criteria:
- Individuals < 18 years old.
- Contraindications to exercise testing.
- Currently pregnant.
- Musculoskeletal or metabolic disease.
- Ulcer or tumor in the esophagus.
- Allergies to latex.
- Allergies to lidocaine.
- Body-mass index ≤ 18 or ≥ 35 kg·m^2.
- Pacemaker.
- No confounding cardiorespiratory disease.
- Persistent tobacco use (> 15 pack years).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 5/10/23. Questions regarding updates should be directed to the study team contact.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Michael Joyner, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available