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Completed

NCT Number: NCT01707277

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Other

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.

Usual Care

Other

Usual pahramacological treatment

Primary outcomes

  1. 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

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

    Time frame: 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´.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

  • University of Valencia

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 16, 2012
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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