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 (THETIS)

January 28, 2020 updated by: Elpen Pharmaceutical Co. Inc.

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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with symptomatic Heart Failure NYHA≥2

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elpen Pharmaceutical Co. Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2019

Primary Completion (ANTICIPATED)

January 31, 2020

Study Completion (ANTICIPATED)

January 31, 2020

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (ACTUAL)

May 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-IVBR-EL-95

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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