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

Chronic Heart Failure Clinical Trial

— SELFIE-TR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578225
• Other study ID #: 288-AU/003
• Status: Completed
• Phase: N/A
• First received: August 28, 2015
• Last updated: January 24, 2018
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2018
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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"

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1054
• Est. completion date: June 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• Non interventional study

Locations

Country	Name	City	State
Turkey	Cukurova University School of Medicine	Adana
Turkey	Kocatepe University School of Medicine	Afyon
Turkey	Hacettepe University School of Medicine	Ankara
Turkey	Yüksek Ihtisas Training and Research Hospital	Ankara
Turkey	Adnan Menderes University School of Medicine	Aydin
Turkey	Hitit University School of Medicine	Corum
Turkey	Trakya University School of Medicine	Edirne
Turkey	Firat University School of Medicine	Elazig
Turkey	Ataturk University School of Medicine	Erzurum
Turkey	Istanbul University Cardiology Institute	Istanbul
Turkey	Siyami Ersek Training and Research Hospital	Istanbul
Turkey	Ege University School of Medicine	Izmir
Turkey	Izmir Tepecik Training And Research Hospital	Izmir
Turkey	Kilis State Hospital	Kilis
Turkey	Kirikkale University School of Medicine	Kirikkale
Turkey	Kocaeli University School of Medicine	Kocaeli
Turkey	Inonu University School of Medicine	Malatya
Turkey	Sutcu Imam University School of Medicine	Maras
Turkey	Mersin University School of Medicine	Mersin
Turkey	Sakarya University School of Medicine	Sakarya
Turkey	Ondokuz Mayis University School of Medicine	Samsun
Turkey	Cumhuriyet University School of Medicine	Sivas
Turkey	Karadeniz Technical University School of Medicine	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Mehmet Birhan Yilmaz

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in patients with acute and chronic heart failure	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).	>1 year after the enrollment is over
Secondary	Guideline directed heart failure medications and outcome	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	Prospective data collection during follow up
Secondary	Co-morbidities and outcome	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.	Prospective survival data collection during follow up