CPAP Versus Bi-level in Chronic Heart Failure

NCT03287141 | Completed

• 1 other identifier: 1a2b3c4d
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

noninvasive ventilation; continuous positive airway pressure; intermittent positive-pressure breathing; exercise test; physical endurance; physical fitness

Outcome Measures

Primary Outcomes (1)

• Physical exercise tolerance

  The distance covered in the shuttle walk test

  Immediately after the test

Secondary Outcomes (6)

• Perception of effort

  before and immediately after the test

• Perception of dyspnea

  before and immediately after the test

• Respiratory rate

  before and immediately after the test

• Peripheral oxygen saturation

  before and immediately after the test

• Heart rate

  before and immediately after the test

Study Arms (3)

First intervention

SHAM COMPARATOR

The subjects did a shuttle walk test without any previous intervention.

Diagnostic Test: Shuttle walk test

Second intervention

EXPERIMENTAL

Subjects underwent 30 minutes of noninvasive ventilation (CPAP) and then re-performed the shuttle walk test.

Device: Noninvasive ventilation (CPAP)

Third intervention

EXPERIMENTAL

Subjects underwent 30 minutes of noninvasive ventilation (Bi-pap) and then re-performed the shuttle walk test.

Device: Noninvasive ventilation (Bi-pap)

Interventions

Shuttle walk test DIAGNOSTIC_TEST

A shuttle walk test was performed without any previous intervention.

First intervention

Noninvasive ventilation (Bi-pap) DEVICE

After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.

Third intervention

Noninvasive ventilation (CPAP) DEVICE

After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.

Second intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Patri-cia Angelica de Miranda Silva Nogueira: lead

MeSH Terms

Conditions

Heart Failure

Interventions

Walk Test; Noninvasive Ventilation; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Positive-Pressure Respiration

Study Officials

• Patrícia Nogueira, PhD

  college professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 19, 2017
• Study Start: October 19, 2015
• Primary Completion: November 23, 2015
• Study Completion: March 23, 2016
• Last Updated: September 20, 2017

Record last verified: 2017-09