Inspiratory Muscle Training for Hospitalized Heart Failure Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled trial will enroll adults with heart failure admitted to the cardiac ICU. It compares an active inspiratory muscle training (IMT) protocol using a Power Breath device to a sham IMT, both following the ICU rehabilitation program. The primary aim is to see if IMT improves inspiratory muscle strength and related hemodynamic and functional outcomes while monitoring safety in the hospital setting. Participants will perform two daily IMT sessions at initial loads of 30-50% of maximal inspiratory pressure, with progression guided by tolerance. The study addresses the gap in short-term gains and safety of IMT for hospitalized heart failure patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of heart failure;
* age over 18 years;
* hospital admission due to heart failure;
* clinical and hemodynamic stability defined as: heart rate \> 40 bpm and \< 130 bpm; systolic blood pressure (SBP) \> 90 mmHg and \< 180 mmHg; mean arterial pressure (MAP) \> 60 mmHg and \< 110 mmHg; respiratory rate \> 5 breaths per minute and \< 40 breaths per minute; peripheral oxygen saturation \> 88%; absence of psychomotor agitation or somnolence

Exclusion Criteria:

* pregnancy;
* head trauma and/or brain injury;
* motor incapacity preventing participation in the institutional rehabilitation protocol of the Cardiointensive Care Unit (ICU);
* signs and/or symptoms of low cardiac output (such as sweating, hypotension, hyperlactatemia, nausea);
* acute coronary syndrome;
* advanced heart failure with left ventricular ejection fraction (LVEF) less than 20%
* presence of untreated tachyarrhythmias or bradyarrhythmias;
* use of inotropes or vasopressors at high doses or dose escalation in the last 24 hours (dobutamine above 15 mcg/kg/min, milrinone above 0.5 mcg/kg/min, norepinephrine above 0.3 mcg/kg/min).

Where it's running

• Pedro Ernesto University Hospital
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
• Carolina Nigro Di Leone
  Rio de Janeiro, Rio de Janeiro, Brazil Not yet recruiting

Study contacts

• Study coordinator: Carolina N DI LEONE, Master degree reseacher
• Email: caroll_nigro@hotmail.com
• Phone: +5521998043470

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.