Powerbreathe / Heart Failure With Reduced Ejection Fraction · Interventional Study

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

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned interventional study registered at Mayo Clinic investigating inspiratory muscle training combined with cardiac rehabilitation in patients with heart failure with reduced ejection fraction. No results have been reported in this registry record; the study is currently recruiting.

What was studied

Interventional, Randomized, Parallel, Double masking, Other purpose. Heart Failure With Reduced Ejection Fraction; age from 18 Years. Intervention: Inspiratory muscle training (IMT). Compared with: SHAM — Sham Comparator. n = 70. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an ongoing trial registration with no results reported; it describes a planned study of inspiratory muscle training in heart failure that has not yet yielded outcome data.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in locomotor muscle blood flow during exercise (assessed at Baseline, 12 weeks); Change in respiratory muscle cost of breathing (VO2) (assessed at Baseline, 12 weeks)

DesignInterventional, Randomized, Parallel, Double masking, Other purpose

PopulationHeart Failure With Reduced Ejection Fraction; age from 18 Years

Sample size70

InterventionInspiratory muscle training (IMT)

ComparatorSHAM — Sham Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment70

Primary outcome measure 1Change in locomotor muscle blood flow during exercise, measured at Baseline and 12 weeks

Primary outcome measure 2Change in respiratory muscle cost of breathing (VO2), measured at Baseline and 12 weeks

Caveats

This is a registry record only; no results are reported or available.
Comparator arm (if any) is not specified in the registry record.
Blinding, randomization method, and allocation concealment are not described.
Study phase is listed as NA; control design and sample allocation strategy are unclear.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional study design stated; phase and comparator arm not specified in registry.

Directness

moderate

Focuses on physiological endpoints (muscle blood flow, respiratory cost) relevant to heart failure.

Consistency

insufficient

Single ongoing trial; no comparison to other studies possible at this stage.

Risk of bias

insufficient

Blinding, randomization method, and allocation concealment not described in registry record.

Sample adequacy

moderate

Planned enrollment 70 participants; adequate for mechanistic physiological study.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07086131). This is a study registration, not published results. Lead sponsor: Mayo Clinic. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 70 participants (ESTIMATED). Conditions: Heart Failure With Reduced Ejection Fraction. Interventions: DEVICE: Powerbreathe. Primary outcome measures: Change in locomotor muscle blood flow during exercise , Baseline, 12 weeks; Change in respiratory muscle cost of breathing (VO2) , Baseline, 12 weeks. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

PowerbreatheHeart Failure With Reduced Ejection FractionNCT07086131Mayo Clinic