Clinical trial NCT02578225: Snapshot Evaluation of Acute and Chronic Heart Failure in Real Life in Turkey
Official title: Acute and Chronic Heart Failure in Real Life in Turkey: National, Multi-center, Epidemiological, Observational and Ad-Hoc Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Keywords: Heart
Chronic
Failure
MI
real life
Turkey
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 1054
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In 23 designated sites, for a month on a day which will be determined by the site itself, patients who have been admitted to the clinic or hospitalized with Heart Failure (Acute and Chronic) diagnosis will be enrolled into the study. Target population of the study is the acute and chronic heart failure patients who will consult to the hospital on the related day of the week for a month which is determined by sites.

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.

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

Primary outcomes:
measure: Survival in patients with acute and chronic heart failure
timeFrame: >1 year after the enrollment is over
Secondary outcomes:
measure: Guideline directed heart failure medications and outcome
timeFrame: Prospective data collection during follow up
measure: Co-morbidities and outcome
timeFrame: Prospective survival data collection during follow up
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University School of Medicine
city: Afyon
country: Turkey
facility: Kocatepe University School of Medicine
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine
city: Ankara
country: Turkey
facility: Yüksek İhtisas Training and Research Hospital
city: Aydın
country: Turkey
facility: Adnan Menderes University School of Medicine
city: Corum
country: Turkey
facility: Hitit University School of Medicine
city: Edirne
country: Turkey
facility: Trakya University School of Medicine
city: Elazig
country: Turkey
facility: Firat University School of Medicine
city: Erzurum
country: Turkey
facility: Ataturk University School of Medicine
city: İstanbul
country: Turkey
facility: İstanbul University Cardiology Institute
city: İstanbul
country: Turkey
facility: Siyami Ersek Training and Research Hospital
city: İzmir
country: Turkey
facility: Ege University School of Medicine
city: İzmir
country: Turkey
facility: İzmir Tepecik Training And Research Hospital
city: Kilis
country: Turkey
facility: Kilis State Hospital
city: Kirikkale
country: Turkey
facility: Kirikkale University School of Medicine
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
city: Malatya
country: Turkey
facility: Inonu University School of Medicine
city: Maras
country: Turkey
facility: Sutcu Imam University School of Medicine
city: Mersin
country: Turkey
facility: Mersin University School of Medicine
city: Sakarya
country: Turkey
facility: Sakarya University School of Medicine
city: Samsun
country: Turkey
facility: Ondokuz Mayis University School of Medicine
city: Sivas
country: Turkey
facility: Cumhuriyet University School of Medicine
city: Trabzon
country: Turkey
facility: Karadeniz Technical University School of Medicine
Study officials:
References: