Exercise and Noninvasive Ventilation in Heart Failure Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-12-31

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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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noninvasive ventilation

Group Type EXPERIMENTAL

noninvasive ventilation

Intervention Type OTHER

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.

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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noninvasive ventilation

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No