Heart Failure Clinical Trial
— CHFOfficial title:
Comparison of CPAP and Bi-level Effects on Exercise Tolerance and Cardiorespiratory Responses in Individuals With Chronic Heart Failure.
Verified date | September 2017 |
Source | Universidade Federal do Rio Grande do Norte |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | March 23, 2016 |
Est. primary completion date | November 23, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Outpatient and have a compensated HF, without hospitalizations in the last three months; 2. Present functional class II and III (New York Heart Association); 3. Present left ventricular ejection fraction (LVEF) = 50%; 4. Have not suffered myocardial infarction in the last three months; 5. No previous diagnosis of chronic obstructive pulmonary disease (FEV1 / FVC ratio> 70% in spirometry); 6. Do not be a smoker; 7. Not being pregnant; 8. Does not present any clinical disease or restriction of osteomioarticular or neurological origin that prevents / limits the carrying out of the proposed tests; 9. Integral cognitive functions, which were evaluated by the cognitive test of Leganés - PCL Exclusion Criteria: 1. Unstable angina or significant arrhythmias; 2. Acute atrial fibrillation or total atrioventricular block; 3. Systemic blood pressure (AP) at uncontrolled rest (= 180/110 mmHg or =80 / 40mmHg); 4. Resting heart rate (HR) = 40 bpm or = 120 bpm; 5. Need for dialysis; 6. Use of bronchodilator; 7. Respiratory rate (RF) at rest = 35 rpm; 8. Frequent vomiting; 9. Intolerance to NIV; 10. infection or fever. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Patri-cia Angelica de Miranda Silva Nogueira |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical exercise tolerance | The distance covered in the shuttle walk test | Immediately after the test | |
Secondary | Perception of effort | The muscular fatigue of the legs | before and immediately after the test | |
Secondary | Perception of dyspnea | The discomfort in the breath | before and immediately after the test | |
Secondary | Respiratory rate | The number of times an individual breathed in a minute. | before and immediately after the test | |
Secondary | Peripheral oxygen saturation | Noninvasive measurement of peripheral oxygen saturation by re-evaluating oxygenation rate. | before and immediately after the test | |
Secondary | Heart rate | Heart rate reflecting heart beats for one minute. | before and immediately after the test | |
Secondary | Blood pressure | Variable blood pressure analysis performed noninvasively. | before and immediately after the test |
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