Heart FailureNCT02869178
Strain X Cardiopulmonary Test
An observational study of Heart Failure, run by Daniella Cunha Brandao at 1 site in Brazil.
Trial summary
Introduction : Patients with heart failure (HF ) with systolic dysfunction of moderate to severe exhibit significant reduction in the ability to exercise compared to those with mild dysfunction , and have worse prognosis. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Heart Failure
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Aug 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adults 21-65 years diagnosed with HF of all etiologies , in functional class II and III by the New York Heart Association ( NYHA ) , sedentary , of both sexes.
Who may be able to join
- moderate and significant systolic dysfunction (LVEF < 45%) assessed by transthoracic echocardiography recent ( last month before evaluation ) Teichholz method , or when in the presence of contractile deficit target , by the Simpson method.
Who cannot join
- deformity in the face to prevent the coupling of the mask to perform the CPET ,
- orthopedic and neurological diseases that could make it impossible to perform the tests ,
- patients with psychiatric disorders that restricted them to respond to the questionnaire ,
- HF FC IV or hospitalization in the last three months ,
- angina unstable;
- myocardial infarction or heart surgery up to three months before the survey ;
- FEV1 / FVC <70 % predicted characterizing obstructive respiratory disorder .
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernmabuco
Recife, Pernambuco
Daniella C Brandão, pHD, +55 81 2126 8000 ext. 8496, daniellacunha@hotmail.com
About this study
Official title: Analysis Of Strain Myocardial Associated With The Exercise Tolerance In Patients With Heart Failure Systolic
Introduction : Patients with heart failure (HF ) with systolic dysfunction of moderate to severe exhibit significant reduction in the ability to exercise compared to those with mild dysfunction , and have worse prognosis. However, some clinical markers of severity and diagnosis widely used in this population such as ejection fraction (EF) , are not always able to translate the actual degree of cardiac damage as well as their relationship with the cardiorespiratory fitness of these individuals and prognosis .
Objective: To evaluate the ability of the global longitudinal strain ( GLS ) in predicting exercise tolerance in heart failure patients with moderate and significant systolic dysfunction.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiography for obtaining the "strain "
To strain of technical analysis will be used echocardiography analysis software ( EchoPAC , GE Medical Systems, Horten , Norway, version 10.0 ) . The images will be analyzed in the longitudinal sections ( 4 bedrooms , 3 bedrooms and 2 cameras) . The endocardium is drawn manually from the septum to the lateral mitral annulus. A region of interest will be applied automatically by the software.
Measured: 1 day
Secondary outcomes (1)
Cardiopulmonary Test
Cardiopulmonary exercise testing will be carried out by the treadmill ramp method ( Centurium 300 , Micromed , Brazil ) through ErgoPC Elite® software associated with the electrocardiogram ( Micromed , Brazil ) with 12 channels. Respiratory variables will be evaluated by a gas analyzer ( Cortex - Metalyzer II , Germany) being obtained in standard conditions of temperature , pressure and humidity ( STPD ) , breath - by - breath , with the patient breathing in a face mask without leaks during exercise. Will be assessed during the test , functional capacity , measured in METs , VO2 , VE / VCO 2 , VE / VCO 2 slope , T1 / 2VO2 and RFC1 .
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2016 (estimated)
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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniella Cunha Brandao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniella Cunha Brandao, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869178
- Sponsor's protocol ID
- Rafael_cardio
- Status last verified
- Aug 2016
- First submitted
- 6 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Becker M, Hoffmann R, Kuhl HP, Grawe H, Katoh M, Kramann R, Bucker A, Hanrath P, Heussen N. Analysis of myocardial deformation based on ultrasonic pixel tracking to determine transmurality in chronic myocardial infarction. Eur Heart J. 2006 Nov;27(21):2560-6. doi: 10.1093/eurheartj/ehl288. Epub 2006 Oct 11.
PubMed 17035253Belohlavek M, Pislaru C, Bae RY, Greenleaf JF, Seward JB. Real-time strain rate echocardiographic imaging: temporal and spatial analysis of postsystolic compression in acutely ischemic myocardium. J Am Soc Echocardiogr. 2001 May;14(5):360-9. doi: 10.1067/mje.2001.110786.
PubMed 11337681Chan J, Hanekom L, Wong C, Leano R, Cho GY, Marwick TH. Differentiation of subendocardial and transmural infarction using two-dimensional strain rate imaging to assess short-axis and long-axis myocardial function. J Am Coll Cardiol. 2006 Nov 21;48(10):2026-33. doi: 10.1016/j.jacc.2006.07.050. Epub 2006 Oct 31.
PubMed 17112992
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis Of Strain Myocardial Associated With The Exercise Tolerance In Patients With Heart Failure Systolic
- ClinicalTrials.gov ID
- NCT02869178
- Acronym / sponsor ID
- Rafael_cardio
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Daniella Cunha BrandaoUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2016 (estimated)
- First posted
- 16 Aug 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.
Introduction : Patients with heart failure (HF ) with systolic dysfunction of moderate to severe exhibit significant reduction in the ability to exercise compared to those with mild dysfunction , and have worse prognosis. However, some clinical markers of severity and diagnosis widely used in this population such as ejection fraction (EF) , are not always able to translate the actual degree of cardiac damage as well as their relationship with the cardiorespiratory fitness of these individuals and prognosis .
Objective: To evaluate the ability of the global longitudinal strain ( GLS ) in predicting exercise tolerance in heart failure patients with moderate and significant systolic dysfunction.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults 21-65 years diagnosed with HF of all etiologies , in functional class II and III by the New York Heart Association ( NYHA ) , sedentary , of both sexes.
Key inclusion criteria (1 listed)
- moderate and significant systolic dysfunction (LVEF < 45%) assessed by transthoracic echocardiography recent ( last month before evaluation ) Teichholz method , or when in the presence of contractile deficit target , by the Simpson method.
Key exclusion criteria (7 listed)
- deformity in the face to prevent the coupling of the mask to perform the CPET ,
- orthopedic and neurological diseases that could make it impossible to perform the tests ,
- patients with psychiatric disorders that restricted them to respond to the questionnaire ,
- HF FC IV or hospitalization in the last three months ,
- angina unstable;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Echocardiography for obtaining the "strain "
Time frame: 1 day
To strain of technical analysis will be used echocardiography analysis software ( EchoPAC , GE Medical Systems, Horten , Norway, version 10.0 ) . The images will be analyzed in the longitudinal sections ( 4 bedrooms , 3 bedrooms and 2 cameras) . The endocardium is drawn manually from the septum to the lateral mitral annulus. A region of interest will be applied automatically by the software.
1 secondary outcome
Cardiopulmonary Test
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Results publication: PubMed 17035253Becker M, Hoffmann R, Kuhl HP, Grawe H, Katoh M, Kramann R, Bucker A, Hanrath P, Heussen N. Analysis of myocardial deformation based on ultrasonic pixel tracking to determine transmurality in chronic myocardial infarction. Eur Heart J. 2006 Nov;27(21):2560-6. doi: 10.1093/eurheartj/ehl288. Epub 2006 Oct 11.
- Results publication: PubMed 11337681Belohlavek M, Pislaru C, Bae RY, Greenleaf JF, Seward JB. Real-time strain rate echocardiographic imaging: temporal and spatial analysis of postsystolic compression in acutely ischemic myocardium. J Am Soc Echocardiogr. 2001 May;14(5):360-9. doi: 10.1067/mje.2001.110786.
- Results publication: PubMed 17112992Chan J, Hanekom L, Wong C, Leano R, Cho GY, Marwick TH. Differentiation of subendocardial and transmural infarction using two-dimensional strain rate imaging to assess short-axis and long-axis myocardial function. J Am Coll Cardiol. 2006 Nov 21;48(10):2026-33. doi: 10.1016/j.jacc.2006.07.050. Epub 2006 Oct 31.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Daniella Cunha Brandao at 1 site in Brazil.
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 1 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 16 Aug 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniella C Brandão, pHD (+558121268000 ext. 8496, daniellacunha@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiography for obtaining the "strain " (time frame: 1 day). 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 NCT02869178, 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 16 Aug 2016.