RECRUITING

Inspiratory Muscle Training in HFpEF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.

Official Title

Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction

Quick Facts

Study Start:2024-10-09

Study Completion:2028-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06510231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ≥18 yrs of age * Receiving SGLT2 inhibitors and spironolactone (and beta-blocker use for HFpEF patients with hypertension) for \>3 months * NYHA symptoms I-III * Body mass index ≤40 kg/m2 * Currently non-smokers with \<20 pack year history * Able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise)	* Sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1 * Second or third degree heart block * Body mass index \>40 kg/m2 * Current smokers and/or smoking history \>20 pack years * Pregnant women (testing will be done by research team if requested) * Glomerular filtration rate of \<30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1) * Individuals who are not able to engage in exercise * Uremia, history of allergy to iodides * Peripheral artery disease * Alanine transaminase and/or aspartate transaminase greater than 2 times the upper limit of normal (via clinical record within the past 6 months) * Asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea * Ruptured eardrum or any other condition of the ear * History of spontaneous pneumothorax or osteoporosis with a history of rib fractures * History of lidocaine allergy.

Inclusion Criteria

Exclusion Criteria

* ≥18 yrs of age
* Receiving SGLT2 inhibitors and spironolactone (and beta-blocker use for HFpEF patients with hypertension) for \>3 months
* NYHA symptoms I-III
* Body mass index ≤40 kg/m2
* Currently non-smokers with \<20 pack year history
* Able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise)

* Sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1
* Second or third degree heart block
* Body mass index \>40 kg/m2
* Current smokers and/or smoking history \>20 pack years
* Pregnant women (testing will be done by research team if requested)
* Glomerular filtration rate of \<30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1)
* Individuals who are not able to engage in exercise
* Uremia, history of allergy to iodides
* Peripheral artery disease
* Alanine transaminase and/or aspartate transaminase greater than 2 times the upper limit of normal (via clinical record within the past 6 months)
* Asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea
* Ruptured eardrum or any other condition of the ear
* History of spontaneous pneumothorax or osteoporosis with a history of rib fractures
* History of lidocaine allergy.

Contacts and Locations

Study Contact

Joshua Smith, PhD

CONTACT

Smith.Joshua1@mayo.edu

Principal Investigator

Joshua Smith, PhD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Joshua Smith, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-09

Study Completion Date2028-04

Study Record Updates

Study Start Date2024-10-09

Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure