Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) in Patients With Symptomatic Heart Failure

Study Overview
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Brief Summary
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Cardiac Heart Failure Questionnaire HF-Q) to assess the severity of the symptoms of Heart Failure. In this study, modified and translated, the four-point questionnaire by Severo and his associates - Heart Failure Questionnaire HF-Q, is used. The HF-Q Heart Failure Questionnaire consists of four closed questions: the first with four possible answers and the other three questions with the possibility of three simple-choice answers.

Detailed Description
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An important new element in recent guidelines is the recommendation to prevent the onset of heart failure syndrome and / or delay its progression. The degree of patient functional limitation is determined using the New York Heart Association (NYHA) classification, which in combination with the left ventricular ejection fraction is the main criterion for all clinical studies in HF. Specifically, NYHA's functional classification is used to describe the severity of symptoms and exercise tolerance and includes 4 classes (I-IV) : Class I: Unbound in physical activity. Conventional physical activity does not cause fatigue, palpitations or shortness of breath. Class II: Mild limitation to physical activity. No symptoms in the calm, but ordinary physical activity causes fatigue, palpitations or shortness of breath. Class III: Serious restriction to physical activity. No symptoms in the calm, but even mild physical activity causes fatigue, palpitations or shortness of breath. Class IV: Inability to perform any physical activity without discomfort. Symptoms and seclusion. Strengthening the discomfort in any physical activity. The study evaluates the predictive capacity of the Cardiac Deficiency Questionnaire (HF-Q) for the occurrence of Adverse Cardiovascular Stroke (MACE) according to the New York Heart Association (NYHA) Functional Classification of Heart Failure in patients with symptomatic Heart Failure . This type of approach may be useful in the reproducibility of the results and the validity of the NYHA classification system, since the severity of the heart failure symptoms is recorded on the basis of the patient's own perception. The term MACE or Major Unwanted Cardiovascular Syndromes is undoubtedly the most common and complex endpoint in cardiology research. Historically, the term MACE appears to be used in the mid-1990s with its use being mainly limited to the intra-muscular complications associated with transcutaneous coronary interventions (PCIs). Despite the widespread use of the term in clinical trials, the definitions of MACE may differ, which makes it difficult to compare similar studies. The so-called classic 3-point MACE is defined based on the following17: Cardiovascular Death Myocardial infarction Cerebral Episode (Ischemic or Haemorrhagic) In general, MACE terminology is a complex clinical event and includes endpoints that reflect both safety and efficacy.

Official Title
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THETIS: Non-interventional, Multicenter Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) According to New York Heart Association Functional Classification (NYHA) in Patients With Symptomatic Heart Failure

Conditions
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Heart Failure NYHA Class II, Heart Failure, Heart Failure NYHA Class III, Heart Failure NYHA Class IV

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with symptomatic Heart Failure NYHA≥2 Patients who have fully understood the procedures of the study and have signed an informed consent form. Exclusion Criteria: Patients with asymptomatic heart failure (NYHA = 1) Patients with severe motor impairment / mobility impairment (neurological diseases, muscular diseases, severe anemia, previous mobility stroke, severe malignancy, end-stage COPD)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Questionnaire (HF-Q) | HF-Q rating vs NYHA classification | 6 months | 
| Major Adverse Cardiovascular Events (MACEs) | Number of MACEs occured during the study | 6 months |