Chronic Heart Failure Clinical Trial
Official title:
Acute and Chronic Heart Failure in Real Life in Turkey: National, Multi-center, Epidemiological, Observational and Ad-Hoc Cross-sectional Study
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"
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.
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