Heart FailureNCT02811146
Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure
A study testing Bilevel Positive Pressure Airway and Heart rehabilitation in people with Heart Failure, run by Universidade Federal de Pernambuco at 2 sites in Brazil.
Trial summary
The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Bilevel Positive Pressure Airway and Heart rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2016to 1 Jul 2021
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary adults diagnosed with heart failure of ischemic hypertensive or alcoholic etiology;
- Ejection fraction of the left ventricle smaller than 50% (LVEF <50%) assessed by echocardiography simple;
- Recent and functional class II and III by the New York Heart Association (NYHA);
- FEV1 <80% predicted and / or FEV1 / FVC> 70% predicted;
- Clinical stability; Ex-smokers for more than five years;
- No change in the class of drugs within three months prior to the beginning of the study.
Who cannot join
- Patients with unstable angina;
- Myocardial infarction or heart surgery up to three months before the survey;
- FEV1 / FVC <70% predicted characterizing obstructive respiratory disorder;
- Respiratory diseases;
- Smoking;
- Hemodynamic instability;
Show all 10Show fewer
- Trauma of recent face;
- Nausea and vomiting;
- Orthopedic and neurological diseases;
- Psychic changes that restrict them to respond to the questionnaire.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital of the Clinics Federal University of Pernambuco
Recife, Pernambuco, 50670-901
Cardiopulmonary Physiotherapy Laboratory
Recife, Pernambuco, 50740-560
About this study
The study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.
Read the detailed description
BACKGROUND: Heart failure (HF) is a cardiovascular syndrome with enormous impact on public health by high morbidity and mortality rates that are associated. Studies show that changes in striated skeletal muscle of those individuals, possibly caused by progressive physical inactivity, contribute to the construction of the pathophysiology of this disease, emphasizing the importance of exercise for these patients. Exercise programs can be traced safer and related form the actual functional capacity thereof. Cardiac rehabilitation it is a set of activities that aims to ensure that patients with heart disease the best conditions, especially physical. In this context, non-invasive ventilation (NIV) is an alternative to provide an improved tolerance during exercise in patients with HF.
GOALS: Evaluate the effectiveness of the use of NIV association to aerobic exercise in exercise programs supervised during cardiac rehabilitation exercise tolerance and quality of life in patients with heart failure when compared to performing these exercises without ventilatory support.
METHODS: This is a clinical trial, controlled, randomized and blind to be developed with patients arising out of the main Recife reference centers in the care of patients with heart failure. It will be conducted assessments of functional capacity made by cardiopulmonary exercise testing (CPET), the Glittre-ADL test and through the questionnaire Duke Activity Status Index (DASI), assessment of quality of life using the questionnaire Minnesota Living with Heart Failure (MLWHF), and finally, in order to determine a clinical change, will be used to Patient Global Impression of Change Scale (PGIS).
EXPECTED RESULTS: This study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.
- Conditions
- Heart Failure
- Being tested
- Bilevel Positive Pressure Airway, Heart rehabilitation
- Keywords
- Heart Failure, Noninvasive Ventilation, Positive- Pressure Respiration
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilevel Positive Pressure AirwayDevice
Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week
Heart rehabilitationOther
Heart rehabilitation, for 12 weeks, 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary exercise testing | Experimental | Assess whether people who wore noninvasive ventilation during aerobic exercise have greater functional capacity than those who did not wear. Receives: Device: Bilevel Positive Pressure Airway; Other: Heart rehabilitation |
| ADL Glitre test | Experimental | Check that people who wore noninvasive ventilation during aerobic exercise have greater submaximal functional capacity than those who did not wear. Compare a ventilatory metabolic response of the ADL Glitre test with an six-minute walk test. . Receives: Device: Bilevel Positive Pressure Airway; Other: Heart rehabilitation |
| Minnesota Living with Heart Failure | Experimental | Check if people undergoing heart rehabilitation has improved quality of life. Receives: Device: Bilevel Positive Pressure Airway; Other: Heart rehabilitation |
| Bioimpedance balance | Experimental | Check if people undergoing heart rehabilitation has improved the body composition. Receives: Device: Bilevel Positive Pressure Airway; Other: Heart rehabilitation |
| Six-minute walk test | No intervention | Compare a ventilatory metabolic response of the six-minute walk test with an ADL Glitre test. |
| Metabolic ventilatory response | Experimental | To verify if non-invasive ventilation during aerobic exercise modifies the ventilatory metabolic response in patients with heart failure.
Check the metabolic ventilatory response during the Glittre ADL test and six-minute walk test. Receives: Device: Bilevel Positive Pressure Airway; Other: Heart rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary exercise testing
Change in functional capacity
Measured: Baseline and 12 weeks
Glittre-ADL Test
Change in submaximal functional capacity
Measured: Baseline and 12 weeks
Six-Minute Walk Test
Change in submaximal functional capacity
Measured: Baseline
Ventilatory metabolic response during the 6-minute walk test (6MWT) and Glittre-ADL Test
Compare the ventilatory metabolic response of the six-minute walk test and Glittre-ADL Test
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Minnesota Living with Heart Failure
Improved in quality of life
Measured: Baseline and 12 weeks
Bioimpedance scale
Change in the body composition
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2016
- Primary completion31 May 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BRUNA THAYS SANTANA DE ARAÚJO, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811146
- Sponsor's protocol ID
- 54735716.3.0000.5208
- Status last verified
- Oct 2021
- First submitted
- 2 Jun 2016
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation and Noninvasive Ventilation in Heart Failure
- ClinicalTrials.gov ID
- NCT02811146
- Acronym / sponsor ID
- 54735716.3.0000.5208
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Noninvasive Ventilation, Positive- Pressure Respiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 23 Jun 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 study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.
Detailed description
BACKGROUND: Heart failure (HF) is a cardiovascular syndrome with enormous impact on public health by high morbidity and mortality rates that are associated. Studies show that changes in striated skeletal muscle of those individuals, possibly caused by progressive physical inactivity, contribute to the construction of the pathophysiology of this disease, emphasizing the importance of exercise for these patients. Exercise programs can be traced safer and related form the actual functional capacity thereof. Cardiac rehabilitation it is a set of activities that aims to ensure that patients with heart disease the best conditions, especially physical. In this context, non-invasive ventilation (NIV) is an alternative to provide an improved tolerance during exercise in patients with HF.
GOALS: Evaluate the effectiveness of the use of NIV association to aerobic exercise in exercise programs supervised during cardiac rehabilitation exercise tolerance and quality of life in patients with heart failure when compared to performing these exercises without ventilatory support.
METHODS: This is a clinical trial, controlled, randomized and blind to be developed with patients arising out of the main Recife reference centers in the care of patients with heart failure. It will be conducted assessments of functional capacity made by cardiopulmonary exercise testing (CPET), the Glittre-ADL test and through the questionnaire Duke Activity Status Index (DASI), assessment of quality of life using the questionnaire Minnesota Living with Heart Failure (MLWHF), and finally, in order to determine a clinical change, will be used to Patient Global Impression of Change Scale (PGIS).
EXPECTED RESULTS: This study aims to demonstrate the efficacy of NIV continuously in cardiac rehabilitation programs, improvement of exercise tolerance, with consequent reflection in functional capacity and quality of life of this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary exercise testing | Experimental | Device: Bilevel Positive Pressure Airway, Other: Heart rehabilitationAssess whether people who wore noninvasive ventilation during aerobic exercise have greater functional capacity than those who did not wear. |
| ADL Glitre test | Experimental | Device: Bilevel Positive Pressure Airway, Other: Heart rehabilitationCheck that people who wore noninvasive ventilation during aerobic exercise have greater submaximal functional capacity than those who did not wear. Compare a ventilatory metabolic response of the ADL Glitre test with an six-minute walk test. . |
| Minnesota Living with Heart Failure | Experimental | Device: Bilevel Positive Pressure Airway, Other: Heart rehabilitationCheck if people undergoing heart rehabilitation has improved quality of life. |
| Bioimpedance balance | Experimental | Device: Bilevel Positive Pressure Airway, Other: Heart rehabilitationCheck if people undergoing heart rehabilitation has improved the body composition. |
| Six-minute walk test | No intervention | –Compare a ventilatory metabolic response of the six-minute walk test with an ADL Glitre test. |
| Metabolic ventilatory response | Experimental | Device: Bilevel Positive Pressure Airway, Other: Heart rehabilitationTo verify if non-invasive ventilation during aerobic exercise modifies the ventilatory metabolic response in patients with heart failure. Check the metabolic ventilatory response during the Glittre ADL test and six-minute walk test. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sedentary adults diagnosed with heart failure of ischemic hypertensive or alcoholic etiology;
- Ejection fraction of the left ventricle smaller than 50% (LVEF <50%) assessed by echocardiography simple;
- Recent and functional class II and III by the New York Heart Association (NYHA);
- FEV1 <80% predicted and / or FEV1 / FVC> 70% predicted;
- Clinical stability; Ex-smokers for more than five years;
Key exclusion criteria (10 listed)
- Patients with unstable angina;
- Myocardial infarction or heart surgery up to three months before the survey;
- FEV1 / FVC <70% predicted characterizing obstructive respiratory disorder;
- Respiratory diseases;
- Smoking;
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 |
|---|---|---|
| Bilevel Positive Pressure AirwayHeart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week | Device | ADL Glitre test, Bioimpedance balance, Cardiopulmonary exercise testing, Metabolic ventilatory response, Minnesota Living with Heart Failure |
| Heart rehabilitationHeart rehabilitation, for 12 weeks, 3 times a week | Other | ADL Glitre test, Bioimpedance balance, Cardiopulmonary exercise testing, Metabolic ventilatory response, Minnesota Living with Heart Failure |
Primary outcome
Cardiopulmonary exercise testing
Time frame: Baseline and 12 weeks
Change in functional capacity
Glittre-ADL Test
Time frame: Baseline and 12 weeks
Change in submaximal functional capacity
Six-Minute Walk Test
Time frame: Baseline
Change in submaximal functional capacity
Ventilatory metabolic response during the 6-minute walk test (6MWT) and Glittre-ADL Test
Time frame: Baseline and 12 weeks
Compare the ventilatory metabolic response of the six-minute walk test and Glittre-ADL Test
2 secondary outcomes
Minnesota Living with Heart Failure
Time frame: Baseline and 12 weeks
Bioimpedance scale
Time frame: Baseline and 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 5 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilevel Positive Pressure Airway and Heart rehabilitation in people with Heart Failure, run by Universidade Federal de Pernambuco at 2 sites 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 10 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Cardiopulmonary exercise testing (time frame: Baseline and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2021.