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Chronic Heart FailureSELFIE-TRNCT02578225

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

An observational study of Chronic Heart Failure, run by Prof. Dr. Mehmet Birhan Yılmaz at 23 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
Non interventional study
How many people
1,054 participants
Where
23 sitesTurkey (Türkiye)
Study dates
Oct 2015to Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Turkey (Türkiye)23 sites

  • Cukurova University School of Medicine

    Adana

  • Kocatepe University School of Medicine

    Afyonkarahisar

  • Hacettepe University School of Medicine

    Ankara

  • Yüksek İhtisas Training and Research Hospital

    Ankara

  • Adnan Menderes University School of Medicine

    Aydin

  • Hitit University School of Medicine

    Çorum

  • Trakya University School of Medicine

    Edirne

  • Firat University School of Medicine

    Elâzığ

  • Ataturk University School of Medicine

    Erzurum

  • İstanbul University Cardiology Institute

    Istanbul

  • Siyami Ersek Training and Research Hospital

    Istanbul

  • Ege University School of Medicine

    Izmir

  • İzmir Tepecik Training And Research Hospital

    Izmir

  • Kilis State Hospital

    Kilis

  • Kirikkale University School of Medicine

    Kirikkale

  • Kocaeli University School of Medicine

    Kocaeli

  • Inonu University School of Medicine

    Malatya

  • Sutcu Imam University School of Medicine

    Maras

  • Mersin University School of Medicine

    Mersin

  • Sakarya University School of Medicine

    Sakarya

  • Ondokuz Mayis University School of Medicine

    Samsun

  • Cumhuriyet University School of Medicine

    Sivas

  • Karadeniz Technical University School of Medicine

    Trabzon

Other trials in Turkey (Türkiye)

About this study

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"

Read the 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.

Being tested
Non interventional study
Keywords
Heart, Chronic, Failure, MI, real life, Turkey
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non interventional studyOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: >1 year after the enrollment is over

Secondary outcomes (2)

  1. 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

    Measured: Prospective data collection during follow up

  2. 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.

    Measured: Prospective survival data collection during follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2016
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,054 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02578225
Sponsor's protocol ID
288-AU/003
Acronym
SELFIE-TR
Status last verified
Jan 2018
First submitted
28 Aug 2015
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Heart Failure, run by Prof. Dr. Mehmet Birhan Yılmaz at 23 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival in patients with acute and chronic heart failure (time frame: >1 year after the enrollment is over). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02578225.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.

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