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

NCT ID: NCT02578225

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1054 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-06-30

Brief Summary

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"

Detailed Description

STUDY DESIGN STEPS

1. 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.

Conditions

Chronic Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Non interventional study

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Mehmet Birhan Yılmaz

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Mehmet Birhan Yılmaz

Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cukurova University School of Medicine

Adana, , Turkey (Türkiye)

Kocatepe University School of Medicine

Afyonkarahisar, , Turkey (Türkiye)

Hacettepe University School of Medicine

Ankara, , Turkey (Türkiye)

Yüksek İhtisas Training and Research Hospital

Ankara, , Turkey (Türkiye)

Adnan Menderes University School of Medicine

Aydin, , Turkey (Türkiye)

Hitit University School of Medicine

Çorum, , Turkey (Türkiye)

Trakya University School of Medicine

Edirne, , Turkey (Türkiye)

Firat University School of Medicine

Elâzığ, , Turkey (Türkiye)

Ataturk University School of Medicine

Erzurum, , Turkey (Türkiye)

İstanbul University Cardiology Institute

Istanbul, , Turkey (Türkiye)

Siyami Ersek Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Ege University School of Medicine

Izmir, , Turkey (Türkiye)

İzmir Tepecik Training And Research Hospital

Izmir, , Turkey (Türkiye)

Kilis State Hospital

Kilis, , Turkey (Türkiye)

Kocaeli University School of Medicine

Kocaeli, , Turkey (Türkiye)

Kirikkale University School of Medicine

Kırıkkale, , Turkey (Türkiye)

Inonu University School of Medicine

Malatya, , Turkey (Türkiye)

Sutcu Imam University School of Medicine

Maras, , Turkey (Türkiye)

Mersin University School of Medicine

Mersin, , Turkey (Türkiye)

Sakarya University School of Medicine

Sakarya, , Turkey (Türkiye)

Ondokuz Mayis University School of Medicine

Samsun, , Turkey (Türkiye)

Cumhuriyet University School of Medicine

Sivas, , Turkey (Türkiye)

Karadeniz Technical University School of Medicine

Trabzon, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

288-AU/003

Identifier Type: -

Identifier Source: org_study_id