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

Fundación para la Investigación del Hospital Clínico de Valencia26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Patients were instructed to train at home twice daily for 20 minutes each session during 12 weeks with a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them were trained under the supervision of a physiotherapist and educated to maintain diaphragmatic breathing during training. The subjects started breathing at a resistance equal to 25-30% of their maximum inspiratory pressure for 1 week.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in exercise capacity parameters at 12-weeks.

Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test

Time frame: 12 weeks

Secondary Outcomes

Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.

Quality of life: Minnesota Living With Heart Failure Questionnaire. Biomarkers: plasma natriuretic peptides, estimaated glomerular filtration rate, antigen carbohydrate 125. Diastolic function: E/e´.