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NCT Number: NCT07086131

A Study Investigating the Impact of IMT With CR On Exercise Responses In HF

The purpose of this study is to compare the impact of inspiratory muscle training (IMT) combined with cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Joshua R Smith

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HFrEF Patients: (≥18 yrs) receiving guideline directed pharmacologic medical therapy for >6 weeks (those with contraindications to medical therapy will meet inclusion criteria), NYHA symptoms I-III, no hospitalizations in the >3 months, have a body mass index ≤45 kg/m2, currently be non-smokers with <30 pack year history and be able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise).

Exclusion criteria

  • sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1;
  • second or third degree heart block;
  • body mass index >45 kg/m2;
  • current smokers and/or smoking history >30 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;
  • symptomatic peripheral artery disease;
  • 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 lung disease.

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.

Treatment and study plan

Powerbreathe

Device

The breathing training will consist of using the PowerBreathe for 12 weeks. The PowerBreathe is an inspiratory pressure threshold trainer. The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device.

Primary outcomes

  1. Change in locomotor muscle blood flow during exercise

    Time frame: Baseline, 12 weeks

    Locomotor muscle blood flows will be measured via Doppler-ultrasound. This will be measured in mL/min.

  2. Change in respiratory muscle cost of breathing (VO2)

    Time frame: Baseline, 12 weeks

    Respiratory muscle cost of breathing is the oxygen uptake (VO2) to the respiratory muscles. Respiratory muscle VO2 is expressed as milliliters of oxygen per kilogram of body mass per minute.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Bruhn, M.A

CONTACT

[email protected]

507-266-2690

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Impact Of Adding Inspiratory Muscle Training To Cardiac Rehabilitation On Exercise Responses In Heart Failure

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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