Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of HFpEF (TRAINING-HF)
Heart Failure With Normal Ejection Fraction
About this trial
This is an interventional treatment trial for Heart Failure With Normal Ejection Fraction focused on measuring heart failure with preserved ejection fraction, physical therapy, exercise capacity, quality of life
Eligibility Criteria
Inclusion Criteria:
Previous history of symptomatic heart failure NYHA (New York Heart Association )functional class ≥II with Normal left ventricular ejection fraction:
- ejection fraction >0.50 by Simpson method
- end-diastolic diameter <60 mm
Structural heart disease:
- left ventricle hypertrophy/left atrial enlargement and/or
- diastolic dysfunction estimated by 2D echocardiography
- Previous admission for acute heart failure
- Clinical stability, without hospital admissions in the past 3 month
Exclusion Criteria:
- Perform a valid baseline exercise test
- Significant primary moderate to severe valvular disease
- Acute coronary syndrome or cardiac surgery within the previous three months
- Signs of ischemia during cardiopulmonary exercise testing
- Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease
- Any other comorbidity with an expectancy of life less than one year
Sites / Locations
- Hospital clínico universitario de Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Standard treatment
IMT group
FES group
IMT+FES group
Only standard medical treatment
Standard medical treatment associated to Inspiratory muscle training
Standard medical treatment associated to functional electrostimulation of both legs for 45 minutes a day, 2 days per week for a total of 12 weeks.
Standard medical treatment associated to combination of inspiratory muscle training and functional electrostimulation of both legs