Exercise and Noninvasive Ventilation in Heart Failure Patients

Study Overview
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Brief Summary
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Introduction: Dyspnea and fatigue determine exercise intolerance in heart failure (HF) subjects, hampering performance in activities of daily living. In this context, noninvasive ventilation (NIV) has been used to minimize such impairment, increasing functional capacity Aim: To evaluate the impact of NIV on exercise performance in HF individuals. Methods: A randomized crossover clinical trial with allocation concealment consisted of two experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level ventilation was performed. Any type of ventilator support was offered during control phase. Functional capacity was assessed by cardiopulmonary exercise test on a treadmill.

Official Title
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Impact of Noninvasive Ventilation With Two Levels of Pressure on Exercise Tolerance in Subjects With Heart Failure: Randomized and Controlled Clinical Trial.

Conditions
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Heart Failure

Intervention / Treatment
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* Other: noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes, 18-60 years body mass index (BMI) <30 kg/m2 functional class II-III according to the New York Heart Association of the echocardiogram últiimos 6 months showing ejection fraction (LVEF) ≤ 45% - echocardiogram of six months showing cardiac hypertrophy (left Ventricular Diastolic Diameter (LVDD)> 55mm Diameter Systolic left Ventricular (LVSD)> 45mm ) optimized from the point of view of drug and (6) clinical stability Exclusion Criteria: (1) unstable angina, myocardial infarction or heart surgery three months before the beginning of the research (2) chronic orthopedic, infectious or metabolic diseases (3) FEV1/FVC <70% predicted characterizing obstructive respiratory disorder; (4) active smokers (5) Limitation on the use of NIV: claustrophobia, inability to remain with their mouths closed, abdominal distention, hemodynamic instability, heart rate (HR) <60 bpm, recent trauma, nausea and vomiting face

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: noninvasive ventilation<br> | Other: noninvasive ventilation<br>* Ventilatory support with bilevel positive pressure was held for 30 minutes with the volunteer sitting comfortably. A fan with two pressure levels (Vivo 40 Bi-Level, General Electric Company), which was attached to the face of the individual through a face Macara ( Respironics), was initially adopted one of 15 cmH2O IPAP and EPAP was used 5 cmH2O, making admissible pressure of 10 cm H2O, where the IPAP would be increased, subject to the comfort of the patient until the patient reached a tidal volume of 6-8 ml / kg, not exceeding the maximum of 20 cmH2O for IPAP.<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary Exercise Test | Cardiopulmonary exercise testing ( CPET ) was performed with symptom-limited ramp protocol (Silva et al . , 2003 ) treadmill ( Centurium 300 Micromed, Brazil ) through ErgoPC Elite ® software associated with electrocardiogram ( Micromed , Brazil ) with 12 channels . The test was performed under standard conditions of temperature, pressure and humidity ( STPD ) , breath-by - breath, being voluntary breathing in a face mask leak during exercise . Before each test the calibration of the equipment for pressure and gas volume was carried out. To ensure that patients reached the maximum effort during the examination were considered tests where patients present a respiratory exchange ratio ( R) ≥ 1.1 ( ARENA , et al 2011) . | Seven days |