Clinical trial NCT01707277: The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
Official title: The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure with preserved ejection fraction
Inspiratory muscle training
Exercise capacity
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2012-10-16
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Changes in exercise capacity parameters at 12-weeks.
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario
Study officials:
affiliation: Hospital Clínico Universitario de Valencia
name: Julio Núñez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin SJ, McElfresh J, Hall B, Bloom R, Farrell K. Inspiratory muscle training in patients with heart failure: a systematic review. Cardiopulm Phys Ther J. 2012 Sep;23(3):29-36.
citation: Diaz-Buschmann I, Jaureguizar KV, Calero MJ, Aquino RS. Programming exercise intensity in patients on beta-blocker treatment: the importance of choosing an appropriate method. Eur J Prev Cardiol. 2014 Dec;21(12):1474-80. doi: 10.1177/2047487313500214. Epub 2013 Aug 5.
citation: Palau P, Dominguez E, Nunez E, Schmid JP, Vergara P, Ramon JM, Mascarell B, Sanchis J, Chorro FJ, Nunez J. Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction. Eur J Prev Cardiol. 2014 Dec;21(12):1465-73. doi: 10.1177/2047487313498832. Epub 2013 Jul 17.