Heart Failure With Normal Ejection Fraction Clinical Trial
— TRAINING-HFOfficial title:
Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction
Verified date | May 2017 |
Source | Universitat Jaume I |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent form of HF in developed countries. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination of both improve exercise capacity as well as left ventricular diastolic function, biomarkers' profile, quality of life (QoL) and prognosis in patients with HFpEF.
Status | Completed |
Enrollment | 52 |
Est. completion date | March 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital clínico universitario de Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Universitat Jaume I | Hospital Clínico Universitario de Valencia, INCLIVA |
Spain,
Palau P, Domínguez E, Núñez E, Schmid JP, Vergara P, Ramón JM, Mascarell B, Sanchis J, Chorro FJ, Núñez J. Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction. Eur J Prev Cardiol. 2014 Dec;21(12):1465-73. doi: 10.1177/2047487313498832. Epub 2013 Jul 17. — View Citation
Palau P, Núñez E, Domínguez E, Sanchis J, Núñez J. Physical therapy in heart failure with preserved ejection fraction: A systematic review. Eur J Prev Cardiol. 2016 Jan;23(1):4-13. doi: 10.1177/2047487314562740. Epub 2014 Dec 8. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional capacity measured as peak oxygen uptake (peak VO2) in ml/min/kg . | Maximal functional capacity will be evaluated with an incremental and symptom-limited cardiopulmonary exercise testing (CORTEX Metamax 3B) on a bicycle ergometer, beginning with a workload of 10 W and increasing stepwise at 10-W increments every 1 min. During exercise, patients were continuously monitored with twelve-lead electrocardiogram and blood pressure measurements every 2 min. Gas exchange data and cardiopulmonary variables were averaged every 10 seconds values. Peak VO2 is considered the highest value of VO2 during the last 20 s of exercise. The improvement > of 10% in peak VO2 will be considered clinically meaningful |
changes at 12 weeks and 6 months | |
Secondary | Functional capacity measured as distance walked in 6 minutes | Patients will be instructed to cover the maximum distance (meters) possible in six minutes, at a self-graded walking speed, pausing to rest when needed. Each subject will undergo 4 tests. The goal of the first one was to allow the patient to familiarize with the test. | changes at 12 weeks and 6 months | |
Secondary | Change in echocardiographic parameter of diastolic disfunction: e' septal (cm/s) | Doppler echocardiogram examination of e' septal (cm/s) will be performed under resting conditions using 2D echocardiography (iE33, Philips). e' septal (cm/s) parameter will be measured according to current guidelines of the European Society of Echocardiography: Only significant improvements in this parameter will be considered |
changes in rest at 12 weeks and 6 months | |
Secondary | Change in echocardiographic parameter of diastolic disfunction: left atrial volume index (mm/m2) | Doppler echocardiogram examination of left atrial volume index (mm/m2) will be performed under resting conditions using 2D echocardiography (iE33, Philips). Left atrial volume index (mm/m2) will be measured according to current guidelines of the European Society of Echocardiography. Only significant improvements in this parameter will be considered |
changes in rest at 12 weeks and 6 months | |
Secondary | Change in echocardiographic parameter of diastolic disfunction: E/e' ratio | Doppler echocardiogram examination of E/e' ratio will be performed under resting conditions using 2D echocardiography (iE33, Philips). E/e' ratio parameter will be measured according to current guidelines of the European Society of Echocardiography. Only significant improvement in this parameter will be considered |
changes in rest at 12 weeks and 6 months | |
Secondary | Change in health-related QoL | Change in health-related QoL will be measured by the Minnesota Living With Heart Failure Questionnaire (no units) Only significant improvements in these parameters will be considered | changes at 12 weeks and 6 months | |
Secondary | Number of rehospitalizations or worsening HF at 6 months | Number of episodes of acute HF hospitalizations and number of episodes of worsening HF not requiring hospitalization at 6 months among different arms. | changes at 6 months |
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