Heart FailureNCT01707277
The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
A study testing Inspiratory muscle training in people with Heart Failure, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Inspiratory muscle training, Usual care
- Keywords
- Heart failure with preserved ejection fraction, Inspiratory muscle training, Exercise capacity
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
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 careOther
Usual pahramacological treatment
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training | Experimental | Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care) Receives: Other: Inspiratory muscle training; Other: Usual care |
| Usual care | Active comparator | Pharmacological treatment Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in exercise capacity parameters at 12-weeks.
Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test
Measured: 12 weeks
Secondary outcomes (1)
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´.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Julio Nuñez, University of Valencia
- Investigators
- Julio Núñez, MD, Principal investigator, Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707277
- Sponsor's protocol ID
- EMI
- Status last verified
- Feb 2016
- First submitted
- 9 Oct 2012
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22993500Diaz-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.
PubMed 23918838Palau 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.
PubMed 23864363
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT01707277
- Acronym / sponsor ID
- EMI
- Conditions
- Heart Failure
- Keywords
- Heart failure with preserved ejection fraction, Inspiratory muscle training, Exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training | Experimental | Other: Inspiratory muscle training, Other: Usual careInspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care) |
| Usual care | Active comparator | Other: Usual carePharmacological treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingPatients 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 | Inspiratory muscle training |
| Usual careUsual pahramacological treatment | Other | Inspiratory muscle training, Usual care |
Primary outcome
Changes in exercise capacity parameters at 12-weeks.
Time frame: 12 weeks
Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test
1 secondary outcome
Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Background: PubMed 22993500Lin 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.
- Derived from this study: PubMed 23918838Diaz-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.
- Derived from this study: PubMed 23864363Palau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Núñez, MD principal investigator
Hospital Clínico Universitario de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Heart Failure, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in exercise capacity parameters at 12-weeks. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01707277, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.