Snapshot Evaluation of Acute and Chronic Heart Failure in Real Life in Turkey
- Conditions
- Chronic Heart Failure
- Registration Number
- NCT02578225
- Lead Sponsor
- Prof. Dr. Mehmet Birhan Yılmaz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1054
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival in patients with acute and chronic heart failure >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 Outcome Measures
Name Time Method Co-morbidities and outcome 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.
Guideline directed heart failure medications and outcome 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
Trial Locations
- Locations (23)
Kocatepe University School of Medicine
🇹🇷Afyon, Turkey
Sakarya University School of Medicine
🇹🇷Sakarya, Turkey
Cukurova University School of Medicine
🇹🇷Adana, Turkey
Hacettepe University School of Medicine
🇹🇷Ankara, Turkey
Ataturk University School of Medicine
🇹🇷Erzurum, Turkey
Ege University School of Medicine
🇹🇷İzmir, Turkey
Sutcu Imam University School of Medicine
🇹🇷Maras, Turkey
Mersin University School of Medicine
🇹🇷Mersin, Turkey
Hitit University School of Medicine
🇹🇷Corum, Turkey
Trakya University School of Medicine
🇹🇷Edirne, Turkey
Yüksek İhtisas Training and Research Hospital
🇹🇷Ankara, Turkey
Kilis State Hospital
🇹🇷Kilis, Turkey
Kirikkale University School of Medicine
🇹🇷Kirikkale, Turkey
Adnan Menderes University School of Medicine
🇹🇷Aydın, Turkey
Siyami Ersek Training and Research Hospital
🇹🇷İstanbul, Turkey
Inonu University School of Medicine
🇹🇷Malatya, Turkey
Ondokuz Mayis University School of Medicine
🇹🇷Samsun, Turkey
Cumhuriyet University School of Medicine
🇹🇷Sivas, Turkey
Karadeniz Technical University School of Medicine
🇹🇷Trabzon, Turkey
Firat University School of Medicine
🇹🇷Elazig, Turkey
İstanbul University Cardiology Institute
🇹🇷İstanbul, Turkey
İzmir Tepecik Training And Research Hospital
🇹🇷İzmir, Turkey
Kocaeli University School of Medicine
🇹🇷Kocaeli, Turkey