Heart FailureCHFNCT03287141
CPAP Versus Bi-level in Chronic Heart Failure
A study testing Shuttle walk test, Noninvasive ventilation (Bi-pap) and Noninvasive ventilation (CPAP) in people with Heart Failure, run by Patri-cia Angelica de Miranda Silva Nogueira.
Trial summary
Introduction: Dyspnea and fatigue are the main clinical symptoms of heart failure and primarily responsible for exercise intolerance found in this syndrome. Now, It is known that the use of NIV in CPAP mode applied before exercise increases exercise tolerance in people with heart failure; however, it's not yet known… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Shuttle walk test, Noninvasive ventilation (Bi-pap) and Noninvasive ventilation (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2015to 23 Mar 2016
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient and have a compensated HF, without hospitalizations in the last three months;
- Present functional class II and III (New York Heart Association);
- Present left ventricular ejection fraction (LVEF) ≤ 50%;
- Have not suffered myocardial infarction in the last three months;
- No previous diagnosis of chronic obstructive pulmonary disease (FEV1 / FVC ratio> 70% in spirometry);
- Do not be a smoker;
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- Not being pregnant;
- Does not present any clinical disease or restriction of osteomioarticular or neurological origin that prevents / limits the carrying out of the proposed tests;
- Integral cognitive functions, which were evaluated by the cognitive test of Leganés - PCL
Who cannot join
- Unstable angina or significant arrhythmias;
- Acute atrial fibrillation or total atrioventricular block;
- Systemic blood pressure (AP) at uncontrolled rest (≥ 180/110 mmHg or ≤80 / 40mmHg);
- Resting heart rate (HR) ≤ 40 bpm or ≥ 120 bpm;
- Need for dialysis;
- Use of bronchodilator;
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- Respiratory rate (RF) at rest ≥ 35 rpm;
- Frequent vomiting;
- Intolerance to NIV;
- infection or fever.
About this study
Official title: Comparison of CPAP and Bi-level Effects on Exercise Tolerance and Cardiorespiratory Responses in Individuals With Chronic Heart Failure.
Introduction: Dyspnea and fatigue are the main clinical symptoms of heart failure and primarily responsible for exercise intolerance found in this syndrome. Now, It is known that the use of NIV in CPAP mode applied before exercise increases exercise tolerance in people with heart failure; however, it's not yet known if the bi-level mode is able to generate similar or even better results, due to pressure increase of the ventilatory support in this modality. Moreover, it is possible that there is influence between the pressure levels set in the NIV and the magnitude of its effect on the exercise in this population Objective: 1) test for differences between the acute effects of NIV on exercise tolerance in patients with HF, when applied CPAP or bi-level mode; and 2) check for discrepancies in the acute effects of Bi-level mode on the physical performance of these individuals, when applied at different pressure levels. Methodology: This is a controlled, randomized, double-blind and cross-over clinical trial, to be composed of 45 volunteers of both genders, aged between 30 and 80 years, with chronic heart failure, functional class II and III (New York Heart Association) in clinical stability. The experiment will be carried out on four different days, with a 48-hour interval between them, in which NIV will be used in the following modes: Bi-level with minimum parameters (EPAP = 6 cmH2O and IPAP = 12 cmH2O), Bi-level with maximum parameters EPAP = 8 cmH2O and IPAP = 14 cmH2O) and CPAP (6 cmH2O). Thus, all the volunteers will participate in the four TGC. During the tests, distance walking, perceived levels of fatigue and dyspnea, affective response, as well as other physiological variables will be analyzed. Statistical analysis, the ANOVA test for repeated measurements will be used, followed by the Bonferroni post-test, considering p-value less than or equal to 0.05 as statistically significant. Expected Results: This work is expected to improve the therapeutic management of HF patients, assisting in the implementation and improvement of methods to improve dyspnea and muscle fatigue, thus increasing tolerance to exercise.
Read the detailed description
This study is a randomized controlled trial, double-blind and cross-over, to be composed of 45 volunteers of both genders, aged between 30 and 80 years, with CHF will be selected from a specialized outpatient clinic with medical consent. Patients should have symptoms of compensated CHF; presenting functional capacity II and III (New York Heart Association), with left ventricular ejection fraction <50%; not participating in cardiac rehabilitation programs; and clinical stability in the last three months, with no history of angina or coexistence of obstructive pulmonary disease (Tiffeneau-Pinelli index> 70% in spirometry). In addition, they should not present any osteoarticular or neurological disease would prevents them from performing the proposed tests, as well as having a score higher than 22 in the Leganés cognitive test (20). In the case of NIV or exercise intolerance, as well as in case of non-attendance to the experiments on the scheduled days, subjects will be excluded from the study.
The sample will be the result of a non-probabilistic sampling process, calculated based on the magnitude of the effect of the main variable (distance traveled) after the use of NIV therapy, obtained in a pilot study. In addition, this protocol was aproved by the institution's Ethics Committee on Human Research (CAAE: 49324415.0.000.5537).
Experimental procedure The experimental protocol will occur in three visits, one per day, with a minimum interval of 48 hours between them. On the first visit, the volunteers will undergo a screening that consists of clinical evaluation (assessment sheet) and cognitive (Leganéscognitive test), as well as evaluation of lung function (spirometry) and QoL (Minnesota Living with Heart Failure Questionnaire). Next, the Shuttlel Walking Test (SWT) control (T-Co) will be performed, without previous use of NIV, in order to determine the distance traveled and other physiological variables in the absence of interventions. Finally, during the initial visit, a preliminary NIV session will be held to adjust the interface and adapt the volunteer to the therapy.
At each subsequent visit, volunteers will perform a SWT immediately after 30 minutes of NIV, one day in Bi-level mode and one in CPAP mode, following a randomized sequence. Thus, all volunteers will perform one SWT after CPAP (T-CP) and one SWT after Bi-level (T-Bi). In the experiment, the CPAP pressure will be maintained at 6 cmH2O, while at the Bi-level an expiratory pressure (EPAP) of 6 cmH2O and an inspiratory pressure (IPAP) of 12 cmH2O will be defined.
- Conditions
- Heart Failure
- Being tested
- Shuttle walk test, Noninvasive ventilation (Bi-pap), Noninvasive ventilation (CPAP)
- Keywords
- noninvasive ventilation, continuous positive airway pressure, intermittent positive-pressure breathing, exercise test, physical endurance, physical fitness
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shuttle walk testDiagnostic test
A shuttle walk test was performed without any previous intervention.
Noninvasive ventilation (Bi-pap)Device
After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.
Noninvasive ventilation (CPAP)Device
After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.
| Study group | Role | What they receive |
|---|---|---|
| First intervention | Sham comparator | The subjects did a shuttle walk test without any previous intervention. Receives: Diagnostic Test: Shuttle walk test |
| Second intervention | Experimental | Subjects underwent 30 minutes of noninvasive ventilation (CPAP) and then re-performed the shuttle walk test. Receives: Device: Noninvasive ventilation (CPAP) |
| Third intervention | Experimental | Subjects underwent 30 minutes of noninvasive ventilation (Bi-pap) and then re-performed the shuttle walk test. Receives: Device: Noninvasive ventilation (Bi-pap) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical exercise tolerance
The distance covered in the shuttle walk test
Measured: Immediately after the test
Secondary outcomes (6)
Perception of effort
The muscular fatigue of the legs
Measured: before and immediately after the test
Perception of dyspnea
The discomfort in the breath
Measured: before and immediately after the test
Respiratory rate
The number of times an individual breathed in a minute.
Measured: before and immediately after the test
Peripheral oxygen saturation
Noninvasive measurement of peripheral oxygen saturation by re-evaluating oxygenation rate.
Measured: before and immediately after the test
Heart rate
Heart rate reflecting heart beats for one minute.
Measured: before and immediately after the test
Blood pressure
Variable blood pressure analysis performed noninvasively.
Measured: before and immediately after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start19 Oct 2015
- Primary completion23 Nov 2015
- Study completion23 Mar 2016
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patri-cia Angelica de Miranda Silva Nogueira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patri-cia Angelica de Miranda Silva Nogueira, Universidade Federal do Rio Grande do Norte
- Investigators
- Patrícia Nogueira, PhD, Principal investigator, college professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287141
- Sponsor's protocol ID
- 1a2b3c4d
- Acronym
- CHF
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of CPAP and Bi-level Effects on Exercise Tolerance and Cardiorespiratory Responses in Individuals With Chronic Heart Failure.
- ClinicalTrials.gov ID
- NCT03287141
- Acronym / sponsor ID
- CHF / 1a2b3c4d
- Conditions
- Heart Failure
- Keywords
- noninvasive ventilation, continuous positive airway pressure, intermittent positive-pressure breathing, exercise test, physical endurance, physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Patri-cia Angelica de Miranda Silva NogueiraUniversity, hospital or other
- Study start
- 19 Oct 2015
- Primary completion
- 23 Nov 2015 (actual)
- Study completion
- 23 Mar 2016 (actual)
- First posted
- 19 Sep 2017 (actual)
- 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: Dyspnea and fatigue are the main clinical symptoms of heart failure and primarily responsible for exercise intolerance found in this syndrome. Now, It is known that the use of NIV in CPAP mode applied before exercise increases exercise tolerance in people with heart failure; however, it's not yet known if the bi-level mode is able to generate similar or even better results, due to pressure increase of the ventilatory support in this modality. Moreover, it is possible that there is influence between the pressure levels set in the NIV and the magnitude of its effect on the exercise in this population Objective: 1) test for differences between the acute effects of NIV on exercise tolerance in patients with HF, when applied CPAP or bi-level mode; and 2) check for discrepancies in the acute effects of Bi-level mode on the physical performance of these individuals, when applied at different pressure levels. Methodology: This is a controlled, randomized, double-blind and cross-over clinical trial, to be composed of 45 volunteers of both genders, aged between 30 and 80 years, with chronic heart failure, functional class II and III (New York Heart Association) in clinical stability. The experiment will be carried out on four different days, with a 48-hour interval between them, in which NIV will be used in the following modes: Bi-level with minimum parameters (EPAP = 6 cmH2O and IPAP = 12 cmH2O), Bi-level with maximum parameters EPAP = 8 cmH2O and IPAP = 14 cmH2O) and CPAP (6 cmH2O). Thus, all the volunteers will participate in the four TGC. During the tests, distance walking, perceived levels of fatigue and dyspnea, affective response, as well as other physiological variables will be analyzed. Statistical analysis, the ANOVA test for repeated measurements will be used, followed by the Bonferroni post-test, considering p-value less than or equal to 0.05 as statistically significant. Expected Results: This work is expected to improve the therapeutic management of HF patients, assisting in the implementation and improvement of methods to improve dyspnea and muscle fatigue, thus increasing tolerance to exercise.
Detailed description
This study is a randomized controlled trial, double-blind and cross-over, to be composed of 45 volunteers of both genders, aged between 30 and 80 years, with CHF will be selected from a specialized outpatient clinic with medical consent. Patients should have symptoms of compensated CHF; presenting functional capacity II and III (New York Heart Association), with left ventricular ejection fraction <50%; not participating in cardiac rehabilitation programs; and clinical stability in the last three months, with no history of angina or coexistence of obstructive pulmonary disease (Tiffeneau-Pinelli index> 70% in spirometry). In addition, they should not present any osteoarticular or neurological disease would prevents them from performing the proposed tests, as well as having a score higher than 22 in the Leganés cognitive test (20). In the case of NIV or exercise intolerance, as well as in case of non-attendance to the experiments on the scheduled days, subjects will be excluded from the study.
The sample will be the result of a non-probabilistic sampling process, calculated based on the magnitude of the effect of the main variable (distance traveled) after the use of NIV therapy, obtained in a pilot study. In addition, this protocol was aproved by the institution's Ethics Committee on Human Research (CAAE: 49324415.0.000.5537).
Experimental procedure The experimental protocol will occur in three visits, one per day, with a minimum interval of 48 hours between them. On the first visit, the volunteers will undergo a screening that consists of clinical evaluation (assessment sheet) and cognitive (Leganéscognitive test), as well as evaluation of lung function (spirometry) and QoL (Minnesota Living with Heart Failure Questionnaire). Next, the Shuttlel Walking Test (SWT) control (T-Co) will be performed, without previous use of NIV, in order to determine the distance traveled and other physiological variables in the absence of interventions. Finally, during the initial visit, a preliminary NIV session will be held to adjust the interface and adapt the volunteer to the therapy.
At each subsequent visit, volunteers will perform a SWT immediately after 30 minutes of NIV, one day in Bi-level mode and one in CPAP mode, following a randomized sequence. Thus, all volunteers will perform one SWT after CPAP (T-CP) and one SWT after Bi-level (T-Bi). In the experiment, the CPAP pressure will be maintained at 6 cmH2O, while at the Bi-level an expiratory pressure (EPAP) of 6 cmH2O and an inspiratory pressure (IPAP) of 12 cmH2O will be defined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First intervention | Sham comparator | Diagnostic Test: Shuttle walk testThe subjects did a shuttle walk test without any previous intervention. |
| Second intervention | Experimental | Device: Noninvasive ventilation (CPAP)Subjects underwent 30 minutes of noninvasive ventilation (CPAP) and then re-performed the shuttle walk test. |
| Third intervention | Experimental | Device: Noninvasive ventilation (Bi-pap)Subjects underwent 30 minutes of noninvasive ventilation (Bi-pap) and then re-performed the shuttle walk test. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Outpatient and have a compensated HF, without hospitalizations in the last three months;
- Present functional class II and III (New York Heart Association);
- Present left ventricular ejection fraction (LVEF) ≤ 50%;
- Have not suffered myocardial infarction in the last three months;
- No previous diagnosis of chronic obstructive pulmonary disease (FEV1 / FVC ratio> 70% in spirometry);
Key exclusion criteria (10 listed)
- Unstable angina or significant arrhythmias;
- Acute atrial fibrillation or total atrioventricular block;
- Systemic blood pressure (AP) at uncontrolled rest (≥ 180/110 mmHg or ≤80 / 40mmHg);
- Resting heart rate (HR) ≤ 40 bpm or ≥ 120 bpm;
- Need for dialysis;
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 |
|---|---|---|
| Shuttle walk testA shuttle walk test was performed without any previous intervention. | Diagnostic test | First intervention |
| Noninvasive ventilation (Bi-pap)After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test. | Device | Third intervention |
| Noninvasive ventilation (CPAP)After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test. | Device | Second intervention |
Primary outcome
Physical exercise tolerance
Time frame: Immediately after the test
The distance covered in the shuttle walk test
6 secondary outcomes
Perception of effort
Time frame: before and immediately after the test
Perception of dyspnea
Time frame: before and immediately after the test
Respiratory rate
Time frame: before and immediately after the test
Peripheral oxygen saturation
Time frame: before and immediately after the test
Heart rate
Time frame: before and immediately after the test
Blood pressure
Time frame: before and immediately after the test
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 20 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Patrícia Nogueira, PhD principal investigator
college professor
Questions about this trial
What is this clinical trial studying?
A study testing Shuttle walk test, Noninvasive ventilation (Bi-pap) and Noninvasive ventilation (CPAP) in people with Heart Failure, run by Patri-cia Angelica de Miranda Silva Nogueira.
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 9 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 20 Sep 2017. 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. Some participants in this study may receive a placebo. 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?
Physical exercise tolerance (time frame: Immediately after the test). 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 20 Sep 2017.