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

This study has been completed.
Sponsor:
Collaborator:
Fundación para la Investigación del Hospital Clínico de Valencia
Information provided by (Responsible Party):
Julio Núñez,MD, University of Valencia
ClinicalTrials.gov Identifier:
NCT01707277
First received: October 9, 2012
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Heart Failure
 Other: Inspiratory muscle training
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • Changes in exercise capacity parameters at 12-weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test


Secondary Outcome Measures:
  • Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Quality of life: Minnesota Living With Heart Failure Questionnaire. Biomarkers: plasma natriuretic peptides, estimaated glomerular filtration rate, antigen carbohydrate 125.

    Diastolic function: E/e´.



Enrollment: 26
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707277

Locations
Spain
Hospital Clínico Universitario
Valencia, Spain, 46010
Sponsors and Collaborators
University of Valencia
Fundación para la Investigación del Hospital Clínico de Valencia
Investigators
Principal Investigator: Julio Núñez, MD University of Valencia
  More Information

Publications:

Responsible Party: Julio Núñez,MD, MD, PhD, University of Valencia
ClinicalTrials.gov Identifier: NCT01707277     History of Changes
Other Study ID Numbers: EMI
Study First Received: October 9, 2012
Last Updated: October 12, 2012
Health Authority: Spain: Ethics Committee

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

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013