Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07086131

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

Led by Mayo Clinic · Updated on 2025-09-25

70

Participants Needed

1

Research Sites

203 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with heart failure with reduced ejection fraction
  • Receiving guideline-directed medical therapy for more than 6 weeks or have contraindications to medical therapy
  • New York Heart Association (NYHA) class I to III symptoms
  • No hospitalizations in the past 3 months
  • Body mass index of 45 kg/m2 or less
  • Non-smokers with less than 30 pack years smoking history
  • Able to exercise without significant orthopedic or musculoskeletal limitations
Not Eligible

You will not qualify if you...

  • Sustained ventricular tachycardia or ventricular fibrillation within 21 days before study start
  • Second or third degree heart block
  • Body mass index greater than 45 kg/m2
  • Current smokers or smoking history over 30 pack years
  • Pregnant women
  • Glomerular filtration rate less than 30 mL/min/1.73m2
  • Unable to engage in exercise
  • Symptomatic peripheral artery disease
  • Asthma with frequent or severe exacerbations or low symptom perception
  • Ruptured eardrum or other ear conditions
  • History of spontaneous pneumothorax or osteoporosis with rib fractures
  • History of lung disease
  • Additional exclusions for DEXA scan: recent gastrointestinal contrast or radionuclide use, severe degenerative changes or fractures in measurement areas, inability to remain still for measurement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

E

Eric Bruhn, M.A

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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