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

Heart Failure Clinical Trial

— AWARENESS-HF  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05180396
• Other study ID #: K-J020
• Status: Completed
• Start date: March 12, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: February 2023
• Source: AstraZeneca Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 10, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Questionnaires
Application of a study based questionnaire described in the protocol

Locations

Country	Name	City	State
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Kahramanmaras Sütçü Imam University Medical Faculty	Kahramanmaras
Turkey	Mersin University Medical Faculty	Mersin

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca Turkey	Klinar CRO

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	At the end of the six-month recruitment period, demographic, symptoms, clinical follow-up status, d will be performed on all included patients.	6 months
Primary	Disease Information	At the end of the six-month recruitment period disease information, treatment compliance, and awareness assessment will be performed on all included patients.	6 months
Secondary	HF Risk Factors (BMI, Diabetes, Hypertension, HLP, Tobbaco Use, CV Hereditary, Menapause, MI History and History of CMP in family)	BMI, Diabetes, Hypertension, HLP, Tobbaco Use, CV Hereditary, Menapause, MI History and History of CMP in family	6 months
Secondary	HF Percutaneous Intervention / Operation History (CRT, ICD, CRT-DI, Pacemaker, PKG, CABG and Heart Valve Operations)	CRT, ICD, CRT-DI, Pacemaker, PKG, CABG and Heart Valve Operations	6 months
Secondary	HF Comorbidities (CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS)	(CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS	6 months
Secondary	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)	Glucose, BUN, Creatinine, GFR, Sodium, Potassium, Nt-ProBNP, ALT, AST, ALP, HS-CRP, cTN, Hemoglobine, WBC, Ferritine, TSAD, LDL, tryglyceride, ST3, GGT, INR, ST4)	6 months
Secondary	HF ECHO Results (EF, LA, SID, Mitral Defficiency, SPAB, DID, Septum, SEG Muscle Weakness, Trial Defficiency)	(EF, LA, SID, Mitral Defficiency, SPAB, DID, Septum, SEG Muscle Weakness, Trial Defficiency)	6 Months