The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Changes in exercise capacity parameters at 12-weeks.
Study Overview
Brief Summary
Previous studies have evaluated the effects of inspiratory muscle training in patiens with heart failure and reduced ejection fraction; nevertheless,no evidence endorse the therapeutic role of inspiratory muscle training in patients with heart failure and preserved ejection fraction. The investigators sought to evaluate whether 12-week inspiratory muscle training improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test), as well as left ventricular diastolic function, serum biomarkers and quality of life (Minnesota Living With Heart Failure Questionnaire) in patients with heart failure with preserved ejection fraction and non-reduced inspiratory muscle strength.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •a) previous history of symptomatic heart failure (New York Heart Association [NYHA] functional class ≥II)
- •b) evidence of normal left ventricular ejection fraction, defined by an ejection fraction >0.50 and an end-diastolic diameter <60 mm by 2D echocardiography
- •c) relevant structural heart disease (left ventricle hypertrophy/left atrial enlargement) and/or diastolic dysfunction estimated by 2D echocardiography
- •d) clinical stability, including no admissions in the past 30 days
Exclusion Criteria
- •a) Patients unable to perform a valid baseline exercise test.
- •b) Unstable angina, myocardial infarction or cardiac surgery within the previous three months.
- •c)Known chronic metabolic, orthopedic, infectious disease or previous pulmonary disease;
- •d)Treatment with steroids, hormones, or cancer chemotherapy;
- •e)Reduced maximal inspiratory pressure according to age and sex;
- •f)Active smokers
- •g)Acute decompensation;
- •h)Other comorbidity with an expectancy of life less than one year
Arms & Interventions
Inspiratory muscle training
Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)
Intervention: Inspiratory muscle training (Other)
Inspiratory muscle training
Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)
Intervention: Usual care (Other)
Usual care
Pharmacological treatment
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
Changes in exercise capacity parameters at 12-weeks.
Time Frame: 12 weeks
Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test
Secondary Outcomes
- Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.(12 weeks)
Investigators
Julio Nuñez
MD, PhD
University of Valencia