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Heart FailureHEARTNCT03895073

HEart fAiluRe evaluaTion Questionnaire

An observational study of Heart Failure and Heart Failure NYHA Class III, run by John Parissis at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The "four-point" questionnaire by Severo and his associates was weighted in 2011 in the Portuguese population and aims to characterize the severity of the symptoms of heart failure by providing a way to minimize the reliability of the NYHA classification. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
healthy volunteers
How many people
170 participants
Where
1 siteGreece
Study dates
1 Sep 2018to 25 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Heart failure patients vs Healthy matched controls

Who may be able to join

  • NYHA classification
  • informed consent
  • compliant with study procedures

Who cannot join

  • no informed consent

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Attikon Hospital

    Athens, Attica

Other trials in Greece

About this study

Official title: Observation Study for the Assessment of the "Four-point" Questionnaire by Severo and His Associates and Its Weighting in the Greek Population to Provide a Powerful Tool for Categorizing the Severity of the Symptoms of Heart Failure

The "four-point" questionnaire by Severo and his associates was weighted in 2011 in the Portuguese population and aims to characterize the severity of the symptoms of heart failure by providing a way to minimize the reliability of the NYHA classification. The questionnaire consists of four closed questions, three possible single-choice answers, coded 0, 1 or 2, and has been translated into Greek in accordance with the internationally-based methodology, with forward-backward translation.

Read the detailed description

In clinical practice, the most commonly used classifications of the severity of CA⸱ are the New York Heart Association functional classification (NYHA), which is based on symptoms and exercise capacity11 and has been used in the majority of clinical trials combined with the fraction left ventricular ejection and ACC / AHA (American College of Cardiology Foundation / American Heart Association), which describes the disease according to structural lesions and symptoms.

With NYHA calibration, patients can be classified into four classes (I, II, III, IV) according to conclusions drawn from the medical history and / or observations of their physical activity and in some cases from cardiac function measurements . An attempt has been made to increase the objectivity of the method through a more comprehensive assessment, which will also be based on clinical measurements from electrocardiograms, stress tests, x-rays, echocardiograms, etc. There is a very high variability among clinicians' ratings on classifying patients in classes based on the NYHA functional classification as the class is selected according to the physician's personal assessment of the patient's physical condition. This increases the subjectivity of the particular sorting system. Studies have shown that there is agreement on NYHA calibration between different doctors for the same patient, of 55%, which leads to the conclusion that the use of this scale as the endpoint in clinical research is questionable and inadequate.

Patient self-assessments are more reliable with respect to the subjectivity of assessing the severity of symptoms. This is why maximizing the interest of the scientific community, clinicians and pharmaceutical companies in developing more subjective methods of measuring health status. 30% of all new drugs developed use patient-reported outcomes (PROs) as primary or intermediate endpoints.

The different data collection methods and sampling techniques are methods and methodologies that allow for the reduction of the amount of data to be collected, considering data only as some elements of a subset of the cases under consideration. The questionnaire is a form that includes a series of structured questions, in which the respondent is asked to respond in writing and in a specific order. Questionnaires collect data asking people to answer exactly the same set of questions. They are usually used in a research strategy to collect descriptive and explanatory data about views, behaviors, features, attitudes, etc. The questionnaire is the means of communication between the researcher and the respondents, directly or indirectly, depending on the method of data collection. The structure of the questionnaire, due to its qualities, is the most critical and delicate task, crucial to the success of a statistical survey.

Being tested
healthy volunteers
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • healthy volunteersOther

    Also called healthy vs heart failure

    the questionnaire has been assessed by both groups, healthy and heart failure

Study groups in NCT03895073
Study groupRoleWhat they receive
healthyhealthy volunteers' replies to questionnaire
Receives: Other: healthy volunteers
heart failureheart failure patients' replies the questionnaire
Receives: Other: healthy volunteers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. questionnaire replies

    rating in Severo questionnaire

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study start1 Sep 2018
  3. Primary completion25 Feb 2019
  4. Study completion25 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03895073
Sponsor's protocol ID
IIS-HEART-2018
Acronym
HEART
Status last verified
Mar 2019
First submitted
27 Mar 2019
Last updated
29 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Heart Failure NYHA Class III, run by John Parissis at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

questionnaire replies (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.

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HEart fAiluRe evaluaTion Questionnaire (NCT03895073) | AzTrials