Heart Failure Clinical Trial
Official title:
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
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.
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.
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