A Study to Understand How Feedback from Breathing Muscles Influence Blood Flow and Blood Pressure during Exercise and if this can Reduce a Response in Heart Failure Patients with Breathing Muscle Training

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes 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.
  • Site IRB
    • Rochester, Minnesota: 17-007785
    Sponsor Protocol Number: 17-007785

About this study

The purpose of this study is to understand how feedback from your breathing muscles influence blood flow and blood pressure during exercise and if we can reduce this response in heart failure patients with breathing muscle training.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

HFpEF Patients:

  • Adults(>21 yrs) will have no history of dangerous arrhythmias, not be pacemaker dependent, have a body mass index ≤ 35kg/m2, currently be non-smokers with <15 pack year history and be able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise). Although HF medications may influence multiple physiologic systems, we feel it is important, practical, and safe to study these patients under conditions of optimal care. Concurrent withdrawal of ACE-inhibitor, beta-blocker, digoxin, and/or diuretic therapies would likely be associated with moderate decompensation in a high proportion of patients. Accordingly, the impact of our studies will be generalizable to HF patients receiving standard optimized pharmacologic therapy, consistent with the general community. All patients will be managed by their primary care physician or cardiologist with additional review by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure inclusion and exclusion criteria have been satisfied and participation in exercise testing is safe.

Control Participants:

  • Adults (≥21 years of age) in the absence of a history of HFpEF or HFrEF, pulmonary, neurologic, orthopedic, or other diseases affecting the neuromuscular system.
  • Controls will be matched for age and sex.
  • Additional inclusion criteria include:
    • BMI ≤35kg/m2
    • Current non-smokers with smoking history <15 pack years
    • Those who are able to engage in exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise)

Exclusion Criteria:

  • History of dangerous arrhythmias
  • Body mass index >35 kg/m2
  • Current smokers and/or smoking history >15 pack years
  • Pregnant women
  • Uremia, history of allergy to iodides
  • Impaired renal function
  • Creatinine value greater than or equal to 1.3 mg/dL (via clinical record within the past 6 months)
  •  Diagnosis of liver disease; or
  • Individuals who are not able to engage in exercise.

For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Olson, M.S., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Briana Ziegler

(507)255-7125

Ziegler.Briana@mayo.edu

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CLS-20426678

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