Heart FailureNCT02481388
Optoelectronic Pletysmography and Diaphragmatic Thickness in Heart Failure Patients
An observational study of Heart Failure, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of the right hemidiaphragm and on the contraction speed of the respiratory muscles. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Maximal exercise ramp test
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Jan 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with heart failure
Who may be able to join
- Both sexes, 18-60 years;
- Functional Class II-III according to the New York Heart Association;
- Echocardiography of the last six months showing showing left ventricular ejection fraction (LVEF) ≤ 45% measured by Teichholz method;
- Echocardiography the last six months showing cardiac hypertrophy (Diameter of Left Ventricular Diastolic (LVDD)> 54 mm, diameter of Systolic Left Ventricular (LVSD)> 34mm) 30 measured by Teichholz method;
- Optimized by the medical point of view and
- Clinical stability
Who cannot join
- Unstable angina; myocardial infarction or heart surgery up to three months before the survey;
- Orthopedic diseases, infectious or chronic metabolic diseases;
- The relation between forced expiratory volume in the first second and forced vital capacity (FEV1 / FVC) <70% of predicted characterizing obstructive respiratory disorder and
- Active smokers.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratório de Fisiologia e Fisioterapia Cardiopulmonar
Recife, Pernambuco, 50740560
Daniella C Brandão, PhD, +558121268496, daniellacunha@hotmail.com
About this study
Official title: Effect of Cardiomegaly Associated With Inspiratory Muscle Weakness on Diaphragm Thickness and Chest Wall Volume Distribution in Patients With Heart Failure
The investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method of the present research, a pilot cross-sectional study was conducted with fourteen (14) patients with heart failure, functional class II and III, clinically stable, with cardiomegaly. Two groups were formed: one group with inspiratory muscle weakness (WG) (maximal inspiratory pressure - MIP <70% predicted MIP) and a control group without weakness (CG). The pulmonary and respiratory muscle functions were assessed by spirometry and manometer, respectively. Before and after maximal exercise test, optoelectronic plethysmography was performed to evaluate the distribution of volumes, the kinematics and the contraction speed of chest wall muscles. The high-resolution ultrasonography was also used before and after the maximum test for obtaining diaphragmatic thickness
- Conditions
- Heart Failure
- Being tested
- Maximal exercise ramp test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal exercise ramp testOther
The maximal exercise ramp test, symptom-limited, performed by all patients in the study was performed based on treadmill ramp protocol through ErgoPC Elite® software associated with 12-channels electrocardiogram. Respiratory variables were obtained in standard conditions of temperature, pressure and humidity (StPD), breath-by-breath, with the patient breathing through a face mask without leaks coupled to gas analyzer (Cortex - Metamax 3B, Germany).To ensure that patients reached maximum effort during the examination, only the tests which patients obtain a respiratory exchange ratio (RR) ≥1.1 were accepted .
| Study group | Role | What they receive |
|---|---|---|
| Weakness Group (WG) | Patients with heart failure and a maximum inspiratory pressure (MIP) <70% of predicted MIP to age, considered as inspiratory muscle weakness. Following the recruitment process, these volunteers will be evaluated by spirometry and manovacuometry. Afterwards, volunteers will be also assessed in a maximal exercise ramp test. Before and after the ramp test, the optoelectronic pletysmography will be performed to analyse the chest wall tricompartmental distribution and the shortening velocities of rib cages muscles. Also a high-definition ultrasonography will be performed to measure the right diaphragmatic cupule thickness Receives: Other: Maximal exercise ramp test | |
| Control group (CG) | Patients with heart failure and do not have a maximum inspiratory pressure (MIP) > 70% of predicted MIP to age, considered as inspiratory muscle weakness. Following the recruitment process, these volunteers will be evaluated by spirometry and manovacuometry. Afterwards, volunteers will be also assessed in a maximal exercise ramp test. Before and after the ramp test, the optoelectronic pletysmography will be performed to analyse the chest wall tricompartmental distribution and the shortening velocities of rib cages muscles. Also a high-definition ultrasonography will be performed to measure the right diaphragmatic cupule thickness Receives: Other: Maximal exercise ramp test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickness
A high-definition ultrasound in the the B mode with linear transducer of 7.5 megahertz was used to measure diaphragmatic thickness. In the lateral decubitus position, the transducer was positioned perpendicular to the chest, between the eighth and ninth intercostal spaces between the right anterior and medium axillary lines. Diaphragm was identified by two hyperechoic (bright) lines parallel to the pleural and parietal membranes respectively. The measurement of diaphragm thickness was held from the middle of the pleural line to the middle of peritoneal. The average of 3 final measures taken at the apposition zone obtained: at functional residual capacity (thickness of the relaxed diaphragm - Erel) at the end of the total lung capacity (thickness of the diaphragm contracted - Econt) and during a maximal inspiratory pressure maneuver from functional residual capacity.
Measured: 30 minutes
Chest Wall tricompartmental volumes
The images generated by the triangulation of the infra-red light reflected by 89 markers placed over volunteers' chest walls and captured by 8 cameras allows the visualization of the same thoraxes as entire structure and in its own tricompartmental division: pulmonary rib cage (RCp), abdominal rib age (RCab) and abdomen (AB). Each compartment can be evaluated in terms of their volume variation across the recorded respiratory cycle.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startMay 2014
- Primary completionJan 2015
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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniella Cunha Brandao, Universidade Federal de Pernambuco
- Investigators
- Jasiel F do Nascimento Junior, Bch, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481388
- Sponsor's protocol ID
- jasiel02
- Status last verified
- Jun 2015
- First submitted
- 22 Jun 2015
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.
PubMed 18436118Brandao DC, Lage SM, Britto RR, Parreira VF, de Oliveira WA Jr, Martins SM, Aliverti A, de Andrade Carvalho L, do Nascimento Junior JF, Alcoforado L, Remigio I, de Andrade AD. Chest wall regional volume in heart failure patients during inspiratory loaded breathing. Respir Physiol Neurobiol. 2012 Mar 15;180(2-3):269-74. doi: 10.1016/j.resp.2011.12.002. Epub 2011 Dec 13.
PubMed 22193337Aliverti A, Cala SJ, Duranti R, Ferrigno G, Kenyon CM, Pedotti A, Scano G, Sliwinski P, Macklem PT, Yan S. Human respiratory muscle actions and control during exercise. J Appl Physiol (1985). 1997 Oct;83(4):1256-69. doi: 10.1152/jappl.1997.83.4.1256.
PubMed 9338435
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cardiomegaly Associated With Inspiratory Muscle Weakness on Diaphragm Thickness and Chest Wall Volume Distribution in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02481388
- Acronym / sponsor ID
- jasiel02
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- First posted
- 25 Jun 2015 (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 investigators aimed to evaluate the effects of cardiomegaly associated with inspiratory muscle weakness on tricompartmental distribution of chest wall volumes, on the thickness of the right hemidiaphragm and on the contraction speed of the respiratory muscles. As method of the present research, a pilot cross-sectional study was conducted with fourteen (14) patients with heart failure, functional class II and III, clinically stable, with cardiomegaly. Two groups were formed: one group with inspiratory muscle weakness (WG) (maximal inspiratory pressure - MIP <70% predicted MIP) and a control group without weakness (CG). The pulmonary and respiratory muscle functions were assessed by spirometry and manometer, respectively. Before and after maximal exercise test, optoelectronic plethysmography was performed to evaluate the distribution of volumes, the kinematics and the contraction speed of chest wall muscles. The high-resolution ultrasonography was also used before and after the maximum test for obtaining diaphragmatic thickness
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weakness Group (WG) | – | Other: Maximal exercise ramp testPatients with heart failure and a maximum inspiratory pressure (MIP) <70% of predicted MIP to age, considered as inspiratory muscle weakness. Following the recruitment process, these volunteers will be evaluated by spirometry and manovacuometry. Afterwards, volunteers will be also assessed in a maximal exercise ramp test. Before and after the ramp test, the optoelectronic pletysmography will be performed to analyse the chest wall tricompartmental distribution and the shortening velocities of rib cages muscles. Also a high-definition ultrasonography will be performed to measure the right diaphragmatic cupule thickness |
| Control group (CG) | – | Other: Maximal exercise ramp testPatients with heart failure and do not have a maximum inspiratory pressure (MIP) > 70% of predicted MIP to age, considered as inspiratory muscle weakness. Following the recruitment process, these volunteers will be evaluated by spirometry and manovacuometry. Afterwards, volunteers will be also assessed in a maximal exercise ramp test. Before and after the ramp test, the optoelectronic pletysmography will be performed to analyse the chest wall tricompartmental distribution and the shortening velocities of rib cages muscles. Also a high-definition ultrasonography will be performed to measure the right diaphragmatic cupule thickness |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with heart failure
Key inclusion criteria (6 listed)
- Both sexes, 18-60 years;
- Functional Class II-III according to the New York Heart Association;
- Echocardiography of the last six months showing showing left ventricular ejection fraction (LVEF) ≤ 45% measured by Teichholz method;
- Echocardiography the last six months showing cardiac hypertrophy (Diameter of Left Ventricular Diastolic (LVDD)> 54 mm, diameter of Systolic Left Ventricular (LVSD)> 34mm) 30 measured by Teichholz method;
- Optimized by the medical point of view and
Key exclusion criteria (4 listed)
- Unstable angina; myocardial infarction or heart surgery up to three months before the survey;
- Orthopedic diseases, infectious or chronic metabolic diseases;
- The relation between forced expiratory volume in the first second and forced vital capacity (FEV1 / FVC) <70% of predicted characterizing obstructive respiratory disorder and
- Active smokers.
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 |
|---|---|---|
| Maximal exercise ramp testThe maximal exercise ramp test, symptom-limited, performed by all patients in the study was performed based on treadmill ramp protocol through ErgoPC Elite® software associated with 12-channels electrocardiogram. Respiratory variables were obtained in standard conditions of temperature, pressure and humidity (StPD), breath-by-breath, with the patient breathing through a face mask without leaks coupled to gas analyzer (Cortex - Metamax 3B, Germany).To ensure that patients reached maximum effort during the examination, only the tests which patients obtain a respiratory exchange ratio (RR) ≥1.1 were accepted . | Other | Control group (CG), Weakness Group (WG) |
Primary outcome
Diaphragmatic thickness
Time frame: 30 minutes
A high-definition ultrasound in the the B mode with linear transducer of 7.5 megahertz was used to measure diaphragmatic thickness. In the lateral decubitus position, the transducer was positioned perpendicular to the chest, between the eighth and ninth intercostal spaces between the right anterior and medium axillary lines. Diaphragm was identified by two hyperechoic (bright) lines parallel to the pleural and parietal membranes respectively. The measurement of diaphragm thickness was held from the middle of the pleural line to the middle of peritoneal. The average of 3 final measures taken at the apposition zone obtained: at functional residual capacity (thickness of the relaxed diaphragm - Erel) at the end of the total lung capacity (thickness of the diaphragm contracted - Econt) and during a maximal inspiratory pressure maneuver from functional residual capacity.
Chest Wall tricompartmental volumes
Time frame: 30 minutes
The images generated by the triangulation of the infra-red light reflected by 89 markers placed over volunteers' chest walls and captured by 8 cameras allows the visualization of the same thoraxes as entire structure and in its own tricompartmental division: pulmonary rib cage (RCp), abdominal rib age (RCab) and abdomen (AB). Each compartment can be evaluated in terms of their volume variation across the recorded respiratory cycle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Background: PubMed 18436118Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.
- Results publication: PubMed 22193337Brandao DC, Lage SM, Britto RR, Parreira VF, de Oliveira WA Jr, Martins SM, Aliverti A, de Andrade Carvalho L, do Nascimento Junior JF, Alcoforado L, Remigio I, de Andrade AD. Chest wall regional volume in heart failure patients during inspiratory loaded breathing. Respir Physiol Neurobiol. 2012 Mar 15;180(2-3):269-74. doi: 10.1016/j.resp.2011.12.002. Epub 2011 Dec 13.
- Results publication: PubMed 9338435Aliverti A, Cala SJ, Duranti R, Ferrigno G, Kenyon CM, Pedotti A, Scano G, Sliwinski P, Macklem PT, Yan S. Human respiratory muscle actions and control during exercise. J Appl Physiol (1985). 1997 Oct;83(4):1256-69. doi: 10.1152/jappl.1997.83.4.1256.
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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.
Jasiel F do Nascimento Junior, Bch principal investigator
Universidade Federal de Pernambuco
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 Universidade Federal de Pernambuco 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 6 inclusion and 4 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 25 Jun 2015. 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 Brandao, PhD (+558121268496, daniellacunha@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic thickness (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 NCT02481388, 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 25 Jun 2015.