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Completed

NCT Number: NCT02578225

Snapshot Evaluation of Acute and Chronic Heart Failure in Real Life in Turkey

This study, which will be conducted at 23 sites representing the determined NUTS-1 regions in Turkey, in which all patients who were admitted to clinic or were hospitalized with Heart Failure (Acute or Chronic) diagnosis will be enrolled into the study, for a month and on a day of the week which will be determined by the site itself, is a national, multi-center, observational, epidemiological and cross-sectional study. This study is a local study which is planned to be conducted only in Turkey. Included patients of the study will be clinically evaluated by the physicians who are maintaining them and will receive the standard medical treatment which is determined by their physicians in normal life conditions. No experimental intervention or treatment will be received by patients in relation to the enrollment to this study. Therefore, this study does not contain a protocol or a pre-determined visit flowchart. However, patients with Heart Failure diagnosis should grant their consent to the retrospective utilization of their data and questions which will be asked to them about their disease history. Provided that the study's design is non-pharmacological observational, investigators will treat and follow the patients in accordance with their own medical decisions and their best clinical experiences.

"Snapshot Evaluation of Heart Failure in Turkey: Initial Analysis from SELFIE-TR"

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cukurova University School of Medicine, Adana, Turkey (Türkiye)

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About this study

STUDY DESIGN STEPS

  • The steps described below will be taken in accordance with ICD code for acute and chronic heart failure patients with a verified heart failure diagnosis:
  • Verification of patient's heart failure diagnosis according to ICD code.
  • In order to include the patient to the study, signing of the consent form.
  • Documentation of patient demographics, medical history, heart failure history, co-morbidities and risk factors.
  • Prospective recording of findings of physical examination.
  • Retrospective recording of results related to diagnostic methods (biochemistry, blood count and others).
  • Determination of NYHA classification.
  • Determination of pathophysiology and etiology.
  • Recording treatment patterns.
  • Inspection of patient's device usage status (pacemaker, ICD, CRT, LVAD, transplantation).
  • Inspection of hospitalization rates.

SELFIE-HF study starting date is planned as month September of 2015 and it is planned that the physicians will execute study enrollment on an allocated day of the week for 4 weeks. It is also planned that the data collected on months October and November will be inspected and listed and patients will be contacted by phone after 1 year after enrolment date in order to inquire about survival status. Therefore, estimated termination date of the study, with patient follow-up calls, is planned to be the last quarter of 2016.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old and older male and female patients
  • Disregarding the consultation method or the severity of disease, Acute Heart Failure patients who have been hospitalized
  • Chronic Heart Failure patients who have been admitted to clinic
  • Patients who have agreed to participate to the study

Exclusion criteria

  • Patients who have expressed their rejection for study participation
  • Patients without a Heart Failure Diagnosis or whose diagnosis is changed or deemed uncertain during index application

Treatment and study plan

Non interventional study

Other

Primary outcomes

  1. Survival in patients with acute and chronic heart failure

    Time frame: >1 year after the enrollment is over

    Patients with acute and chronic heart failure will be contacted via telephone call at least 1 year after the enrollment to see their survival status and cardiovascular mortality rates will be calculated as an outcome measure and will be compared (acute versus chronic).

Secondary outcomes

  1. Guideline directed heart failure medications and outcome

    Time frame: Prospective data collection during follow up

    Prescription records of patients will be obtained and patients will be classified into two as those with and those without specific prescribed medication, and then these findings will be related to cardiovascular mortality

  2. Co-morbidities and outcome

    Time frame: Prospective survival data collection during follow up

    Records of patients with regard to existing co-morbidities during index event will be collected and then be related to cardiovascular mortality during follow up.

Sponsors and collaborators

Lead sponsor

Prof. Dr. Mehmet Birhan Yılmaz

Other

Registry information

Official study title

Acute and Chronic Heart Failure in Real Life in Turkey: National, Multi-center, Epidemiological, Observational and Ad-Hoc Cross-sectional Study

Acronym: SELFIE-TR

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 16, 2015
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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