The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Inspiratory muscle training; Other: Usual care

• Registration Number: NCT01707277
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-16
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training	Usual care	Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)
Usual care	Usual care	Pharmacological treatment
Inspiratory muscle training	Inspiratory muscle training	Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)

Primary Outcome Measures

Name	Time	Method
Changes in exercise capacity parameters at 12-weeks.	12 weeks	Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test

Secondary Outcome Measures

Name	Time	Method
Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.	12 weeks	Quality of life: Minnesota Living With Heart Failure Questionnaire. Biomarkers: plasma natriuretic peptides, estimaated glomerular filtration rate, antigen carbohydrate 125.; Diastolic function: E/e´.

Trial Locations

Locations (1)

Hospital Clínico Universitario; 🇪🇸 Valencia, Spain