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

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ClinicalTrials.gov Identifier: NCT01707277
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : February 4, 2016
Sponsor:
Collaborator:
University of Valencia
Information provided by (Responsible Party):
Julio Nuñez, University of Valencia

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Inspiratory muscle training Other: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
Study Start Date : March 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Inspiratory muscle training
Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)
 Other: Inspiratory muscle training
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.
Other: Usual care
Usual pahramacological treatment
Active Comparator: Usual care
Pharmacological treatment
 Other: Usual care
Usual pahramacological treatment


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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´.



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707277


Locations
Spain
Hospital Clínico Universitario
Valencia, Spain, 46010
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
University of Valencia
Investigators
Principal Investigator: Julio Núñez, MD Hospital Clínico Universitario de Valencia
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Julio Nuñez, MD, PhD, University of Valencia
ClinicalTrials.gov Identifier: NCT01707277     History of Changes
Other Study ID Numbers: EMI
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016

Keywords provided by Julio Nuñez, University of Valencia:
Heart failure with preserved ejection fraction
Inspiratory muscle training
Exercise capacity

Additional relevant MeSH terms:
Heart Failure
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
 Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes