CPAP Versus Bi-level in Chronic Heart Failure (CHF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shuttle walk test
Noninvasive ventilation (Bi-pap)
Noninvasive ventilation (CPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring noninvasive ventilation, continuous positive airway pressure, intermittent positive-pressure breathing, exercise test, physical endurance, physical fitness
Eligibility Criteria
Inclusion Criteria:
- 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;
- 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
Exclusion Criteria:
- 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;
- Respiratory rate (RF) at rest ≥ 35 rpm;
- Frequent vomiting;
- Intolerance to NIV;
- infection or fever.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
First intervention
Second intervention
Third intervention
Arm Description
The subjects did a shuttle walk test without any previous intervention.
Subjects underwent 30 minutes of noninvasive ventilation (CPAP) and then re-performed the shuttle walk test.
Subjects underwent 30 minutes of noninvasive ventilation (Bi-pap) and then re-performed the shuttle walk test.
Outcomes
Primary Outcome Measures
Physical exercise tolerance
The distance covered in the shuttle walk test
Secondary Outcome Measures
Perception of effort
The muscular fatigue of the legs
Perception of dyspnea
The discomfort in the breath
Respiratory rate
The number of times an individual breathed in a minute.
Peripheral oxygen saturation
Noninvasive measurement of peripheral oxygen saturation by re-evaluating oxygenation rate.
Heart rate
Heart rate reflecting heart beats for one minute.
Blood pressure
Variable blood pressure analysis performed noninvasively.
Full Information
NCT ID
NCT03287141
First Posted
September 12, 2017
Last Updated
September 19, 2017
Sponsor
Patri-cia Angelica de Miranda Silva Nogueira
1. Study Identification
Unique Protocol Identification Number
NCT03287141
Brief Title
CPAP Versus Bi-level in Chronic Heart Failure
Acronym
CHF
Official Title
Comparison of CPAP and Bi-level Effects on Exercise Tolerance and Cardiorespiratory Responses in Individuals With Chronic Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 19, 2015 (undefined)
Primary Completion Date
November 23, 2015 (Actual)
Study Completion Date
March 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patri-cia Angelica de Miranda Silva Nogueira
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
noninvasive ventilation, continuous positive airway pressure, intermittent positive-pressure breathing, exercise test, physical endurance, physical fitness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First intervention
Arm Type
Sham Comparator
Arm Description
The subjects did a shuttle walk test without any previous intervention.
Arm Title
Second intervention
Arm Type
Experimental
Arm Description
Subjects underwent 30 minutes of noninvasive ventilation (CPAP) and then re-performed the shuttle walk test.
Arm Title
Third intervention
Arm Type
Experimental
Arm Description
Subjects underwent 30 minutes of noninvasive ventilation (Bi-pap) and then re-performed the shuttle walk test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Shuttle walk test
Intervention Description
A shuttle walk test was performed without any previous intervention.
Intervention Type
Device
Intervention Name(s)
Noninvasive ventilation (Bi-pap)
Intervention Description
After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.
Intervention Type
Device
Intervention Name(s)
Noninvasive ventilation (CPAP)
Intervention Description
After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.
Primary Outcome Measure Information:
Title
Physical exercise tolerance
Description
The distance covered in the shuttle walk test
Time Frame
Immediately after the test
Secondary Outcome Measure Information:
Title
Perception of effort
Description
The muscular fatigue of the legs
Time Frame
before and immediately after the test
Title
Perception of dyspnea
Description
The discomfort in the breath
Time Frame
before and immediately after the test
Title
Respiratory rate
Description
The number of times an individual breathed in a minute.
Time Frame
before and immediately after the test
Title
Peripheral oxygen saturation
Description
Noninvasive measurement of peripheral oxygen saturation by re-evaluating oxygenation rate.
Time Frame
before and immediately after the test
Title
Heart rate
Description
Heart rate reflecting heart beats for one minute.
Time Frame
before and immediately after the test
Title
Blood pressure
Description
Variable blood pressure analysis performed noninvasively.
Time Frame
before and immediately after the test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
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
Exclusion Criteria:
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;
Respiratory rate (RF) at rest ≥ 35 rpm;
Frequent vomiting;
Intolerance to NIV;
infection or fever.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrícia Nogueira, PhD
Organizational Affiliation
college professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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CPAP Versus Bi-level in Chronic Heart Failure
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