Heart Failure Patients Ventilatory Constraint During Exercise

Overview

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	Contact
Rochester, Minn. Mayo Clinic principal investigator Michael Joyner, M.D.	Open for enrollment	Contact information: Eric Bruhn M.A. (507) 422-0220 Bruhn.Eric@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Joyner, M.D.

Open for enrollment

Contact information:

Eric Bruhn M.A.

(507) 422-0220

Bruhn.Eric@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials