Heart FailureNCT02763982
Cardiac Function and Inspiratory Muscles Performance
An observational study of Heart Failure, run by Universidade Federal de Pernambuco.
Trial summary
The purpose of this study is to determine whether ejection fraction and peak oxygen uptake have correlation on inspiratory muscle strength, chest wall volumes and quality of life in individuals with heart failure. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Physical evaluation
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2016
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both female and male participants are being studied, between 18 to 65 years old, diagnosed with heart failure.
Who may be able to join
- Will be included individuals diagnosed with heart failure, both sexes, aged 18-65 years;
- hemodynamically stable (systolic blood pressure ≤ 140 mmHg; diastolic blood pressure ≤ 90 mmHg; heart rate = 90 bpm);
- self-reported sedentary.
Who cannot join
- Will be excluded individuals with unstable angina were excluded;
- acute myocardial infarction or previous surgery up to three months before the survey;
- musculoskeletal changes, respiratory or chronic metabolic diseases;
- treatment with steroids, hormones or chemotherapy;
- gestation;
- smokers and former smokers assets or liabilities;
- inability to comply with verbal commands appraiser or unsuitability to the evaluation devices.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between Cardiac Function and Inspiratory Muscles Performance, Chest Wall Volumes and Quality of Life in Individuals With Heart Failure
The purpose of this study is to determine whether ejection fraction and peak oxygen uptake have correlation on inspiratory muscle strength, chest wall volumes and quality of life in individuals with heart failure.
- Conditions
- Heart Failure
- Being tested
- Physical evaluation
- Keywords
- left ventricular ejection fraction, peak oxygen uptake, respiratory muscles, quality of life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| G1 | High or normal left ventricular ejection fraction Receives: Other: Physical evaluation | |
| G2 | Moderate left ventricular ejection fraction Receives: Other: Physical evaluation | |
| G3 | Reduced left ventricular ejection fraction Receives: Other: Physical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between left ventricular ejection fraction and peak oxygen uptake on inspiratory muscle strength as assessed by echocardiography, ergospirometer and mouth pressure maneuver, respectively
Measured: through study completion, an average of 6 months
Secondary outcomes (2)
Correlation between left ventricular ejection fraction and peak oxygen uptake on chest wall volumes as assessed by echocardiography, ergospirometer and opto-electronic plethysmography, respectively
Measured: through study completion, an average of 6 months
Correlation between left ventricular ejection fraction and peak oxygen uptake on quality of life as assessed by echocardiography, ergospirometer and Minnesota Living with Heart Failure Questionnaire, respectively
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2016
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peterson Filipe Pinheiro de Lima, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763982
- Sponsor's protocol ID
- 39797414.2.0000.520
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 5 May 2016
- Results posted
- No
Publications
Yamada K, Kinugasa Y, Sota T, Miyagi M, Sugihara S, Kato M, Yamamoto K. Inspiratory Muscle Weakness is Associated With Exercise Intolerance in Patients With Heart Failure With Preserved Ejection Fraction: A Preliminary Study. J Card Fail. 2016 Jan;22(1):38-47. doi: 10.1016/j.cardfail.2015.10.010. Epub 2015 Oct 23.
PubMed 26505812Verissimo P, Casalaspo TJ, Goncalves LH, Yang AS, Eid RC, Timenetsky KT. High prevalence of respiratory muscle weakness in hospitalized acute heart failure elderly patients. PLoS One. 2015 Feb 11;10(2):e0118218. doi: 10.1371/journal.pone.0118218. eCollection 2015.
PubMed 25671566Adamopoulos S, Schmid JP, Dendale P, Poerschke D, Hansen D, Dritsas A, Kouloubinis A, Alders T, Gkouziouta A, Reyckers I, Vartela V, Plessas N, Doulaptsis C, Saner H, Laoutaris ID. Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart failure: The Vent-HeFT trial: a European prospective multicentre randomized trial. Eur J Heart Fail. 2014 May;16(5):574-82. doi: 10.1002/ejhf.70. Epub 2014 Mar 14.
PubMed 24634346Stamm O, Latscha U, Janecek P, Campana A. Development of a special electrode for continuous subcutaneous pH measurement in the infant scalp. Am J Obstet Gynecol. 1976 Jan 15;124(2):193-5. doi: 10.1016/s0002-9378(16)33297-5.
PubMed 2012
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cardiac Function and Inspiratory Muscles Performance, Chest Wall Volumes and Quality of Life in Individuals With Heart Failure
- ClinicalTrials.gov ID
- NCT02763982
- Acronym / sponsor ID
- 39797414.2.0000.520
- Conditions
- Heart Failure
- Keywords
- left ventricular ejection fraction, peak oxygen uptake, respiratory muscles, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (estimated)
- First posted
- 5 May 2016 (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.
The purpose of this study is to determine whether ejection fraction and peak oxygen uptake have correlation on inspiratory muscle strength, chest wall volumes and quality of life in individuals with heart failure.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G1 | – | Other: Physical evaluationHigh or normal left ventricular ejection fraction |
| G2 | – | Other: Physical evaluationModerate left ventricular ejection fraction |
| G3 | – | Other: Physical evaluationReduced left ventricular ejection fraction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both female and male participants are being studied, between 18 to 65 years old, diagnosed with heart failure.
Key inclusion criteria (3 listed)
- Will be included individuals diagnosed with heart failure, both sexes, aged 18-65 years;
- hemodynamically stable (systolic blood pressure ≤ 140 mmHg; diastolic blood pressure ≤ 90 mmHg; heart rate = 90 bpm);
- self-reported sedentary.
Key exclusion criteria (7 listed)
- Will be excluded individuals with unstable angina were excluded;
- acute myocardial infarction or previous surgery up to three months before the survey;
- musculoskeletal changes, respiratory or chronic metabolic diseases;
- treatment with steroids, hormones or chemotherapy;
- gestation;
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 |
|---|---|---|
| Physical evaluation | Other | G1, G2, G3 |
Primary outcome
Correlation between left ventricular ejection fraction and peak oxygen uptake on inspiratory muscle strength as assessed by echocardiography, ergospirometer and mouth pressure maneuver, respectively
Time frame: through study completion, an average of 6 months
2 secondary outcomes
Correlation between left ventricular ejection fraction and peak oxygen uptake on chest wall volumes as assessed by echocardiography, ergospirometer and opto-electronic plethysmography, respectively
Time frame: through study completion, an average of 6 months
Correlation between left ventricular ejection fraction and peak oxygen uptake on quality of life as assessed by echocardiography, ergospirometer and Minnesota Living with Heart Failure Questionnaire, respectively
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Results publication: PubMed 26505812Yamada K, Kinugasa Y, Sota T, Miyagi M, Sugihara S, Kato M, Yamamoto K. Inspiratory Muscle Weakness is Associated With Exercise Intolerance in Patients With Heart Failure With Preserved Ejection Fraction: A Preliminary Study. J Card Fail. 2016 Jan;22(1):38-47. doi: 10.1016/j.cardfail.2015.10.010. Epub 2015 Oct 23.
- Results publication: PubMed 25671566Verissimo P, Casalaspo TJ, Goncalves LH, Yang AS, Eid RC, Timenetsky KT. High prevalence of respiratory muscle weakness in hospitalized acute heart failure elderly patients. PLoS One. 2015 Feb 11;10(2):e0118218. doi: 10.1371/journal.pone.0118218. eCollection 2015.
- Results publication: PubMed 24634346Adamopoulos S, Schmid JP, Dendale P, Poerschke D, Hansen D, Dritsas A, Kouloubinis A, Alders T, Gkouziouta A, Reyckers I, Vartela V, Plessas N, Doulaptsis C, Saner H, Laoutaris ID. Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart failure: The Vent-HeFT trial: a European prospective multicentre randomized trial. Eur J Heart Fail. 2014 May;16(5):574-82. doi: 10.1002/ejhf.70. Epub 2014 Mar 14.
- Results publication: PubMed 2012Stamm O, Latscha U, Janecek P, Campana A. Development of a special electrode for continuous subcutaneous pH measurement in the infant scalp. Am J Obstet Gynecol. 1976 Jan 15;124(2):193-5. doi: 10.1016/s0002-9378(16)33297-5.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Universidade Federal de Pernambuco.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peterson Filipe Pinheiro de Lima, Graduated (+5581998186292, pinheirofilipe@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between left ventricular ejection fraction and peak oxygen uptake on inspiratory muscle strength as assessed by echocardiography, ergospirometer and mouth pressure maneuver, respectively (time frame: through study completion, an average of 6 months). 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 NCT02763982, which also lists 4 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 5 May 2016; AzTrials last refreshed its copy on 28 Oct 2026.