Clinical trial NCT05180396: A Study on Disease Awareness and Treatment Compliance of Heart Failure Patients
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Questionnaire
ECHO
Prospective
Lead sponsor: AstraZeneca Turkey
Sponsor class: INDUSTRY
Collaborators: name: Klinar CRO
First posted: 2022-01-06
Enrollment: 200
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: Cases with the diagnosis of Heart Failure (Acute and Chronic) who were admitted to the outpatient clinic and hospitalized will be included in the study. It is planned to include 200 patients from 3 centers in this study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Demographics
timeFrame: 6 months
measure: Disease Information
timeFrame: 6 months
Secondary outcomes:
measure: HF Risk Factors (BMI, Diabetes, Hypertension, HLP, Tobbaco Use, CV Hereditary, Menapause, MI History and History of CMP in family)
timeFrame: 6 months
measure: HF Percutaneous Intervention / Operation History (CRT, ICD, CRT-DI, Pacemaker, PKG, CABG and Heart Valve Operations)
timeFrame: 6 months
measure: HF Comorbidities (CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS)
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
measure: HF ECHO Results (EF, LA, SID, Mitral Defficiency, SPAB, DID, Septum, SEG Muscle Weakness, Trial Defficiency)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Sütçü İmam University Medical Faculty
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
Study officials:
References: