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Completed

NCT Number: NCT05180396

A Study on Disease Awareness and Treatment Compliance of Heart Failure Patients

The AWARENESS HF-PD is a cross-sectional, multicenter, survey-based study. Cases who were admitted to the outpatient clinic and hospitalized with the diagnosis of Heart Failure (Acute and Chronic) will be included in the study.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz University Medical Faculty, Antalya, Turkey (Türkiye)

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About this study

Data entry personnel to be assigned at the centers throughout the study will apply a questionnaire consisting of different questions to patients referred to them by clinicians with the diagnosis of HF. In addition, clinical features of HF from the current file of the cases (NYHA, comorbid conditions, comorbid diseases, blood pressure, heart rate, latest biochemistry (BNP/NTproBNP if available), hematology test results, most recent ECG, most recent echocardiography , coronary angiography report, if any) will be recorded. No additional examination/procedure will be performed for the study, only the data of the examinations requested by the clinician in routine clinical practice will be entered. A total of 200 patients from 3 centers will be included in this study over a six-month period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients aged 18 and over
  • Patients diagnosed with acute or chronic heart failure
  • Patients who agreed to participate in the study

Exclusion criteria

  • Patients who stated that they did not agree to participate in the study
  • Patients who were not diagnosed with Heart Failure or whose diagnosis was changed or not confirmed during the index application
  • Pregnancy

Treatment and study plan

questionnaires

Other

Application of a study based questionnaire described in the protocol

Primary outcomes

  1. Demographics

    Time frame: 6 months

    At the end of the six-month recruitment period, demographic, symptoms, clinical follow-up status, d will be performed on all included patients.

  2. Disease Information

    Time frame: 6 months

    At the end of the six-month recruitment period disease information, treatment compliance, and awareness assessment will be performed on all included patients.

Secondary outcomes

  1. HF Risk Factors (BMI, Diabetes, Hypertension, HLP, Tobbaco Use, CV Hereditary, Menapause, MI History and History of CMP in family)

    Time frame: 6 months

    BMI, Diabetes, Hypertension, HLP, Tobbaco Use, CV Hereditary, Menapause, MI History and History of CMP in family

  2. HF Percutaneous Intervention / Operation History (CRT, ICD, CRT-DI, Pacemaker, PKG, CABG and Heart Valve Operations)

    Time frame: 6 months

    CRT, ICD, CRT-DI, Pacemaker, PKG, CABG and Heart Valve Operations

  3. HF Comorbidities (CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS)

    Time frame: 6 months

    (CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS

  4. HF Laboratory Results (Glucose, BUN, Creatinine, GFR, Sodium, Potassium, Nt-ProBNP, ALT, AST, ALP, HS-CRP, cTN, Hemoglobine, WBC, Ferritine, TSAD, LDL, tryglyceride, ST3, GGT, INR, ST4)

    Time frame: 6 months

    Glucose, BUN, Creatinine, GFR, Sodium, Potassium, Nt-ProBNP, ALT, AST, ALP, HS-CRP, cTN, Hemoglobine, WBC, Ferritine, TSAD, LDL, tryglyceride, ST3, GGT, INR, ST4)

  5. HF ECHO Results (EF, LA, SID, Mitral Defficiency, SPAB, DID, Septum, SEG Muscle Weakness, Trial Defficiency)

    Time frame: 6 Months

    (EF, LA, SID, Mitral Defficiency, SPAB, DID, Septum, SEG Muscle Weakness, Trial Defficiency)

Sponsors and collaborators

Lead sponsor

AstraZeneca Turkey

Industry

Collaborators

  • Klinar CRO

Registry information

Official study title

A Multicenter, Cross-sectional Study Evaluating the Symptoms, Clinical Follow-ups, Problems Encountered During the Course of the Disease, Disease Awareness and Treatment Compliance of Heart Failure Patients - AWARENESS HF-PD(Patient Diary)

Acronym: AWARENESS-HF

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2022
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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