Status:

COMPLETED

CPAP Versus Bi-level in Chronic Heart Failure

Lead Sponsor:

Patri-cia Angelica de Miranda Silva Nogueira

Conditions:

Heart Failure

Eligibility:

All Genders

40-75 years

Phase:

NA

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 CPA...

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 ou...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 19 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 23 2016

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT03287141

Start Date

October 19 2015

End Date

March 23 2016

Last Update

September 20 2017

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