A Study on Disease Awareness and Treatment Compliance of Heart Failure Patients (AWARENESS-HF)

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)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Questionnaires

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Akdeniz University Medical Faculty
  • Kahramanmaraş, Turkey
    • Kahramanmaraş Sütçü İmam University Medical Faculty
  • Mersin, Turkey
    • Mersin University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases with the diagnosis of Heart Failure (Acute and Chronic); Application of a questionnaire consisting of different questions to patients.	Other: Questionnaires; Application of a study based questionnaire described in the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
HF Comorbidities (CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS)	(CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS	6 months
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca Turkey
• Collaborators: Klinar CRO

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): September 10, 2021

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Questionnaire; Prospective; ECHO
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: K-J020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No