Multicenter Prospective Observational Study Evaluating the Management of Heart Failure

Heart Failure Clinical Trial

— ADAPTATION-HF  

Official title:

Questionnaire-based Multicenter Prospective Observational Study Evaluating Patient Perception, Compliance and Adaptation in the Management of Heart Failure - ADAPTATION HF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05180370
• Other study ID #: K-J019
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: January 31, 2022

Study information

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

Clinical Trial Summary

ADAPTATION HF is a prospective, observational, cross-sectional, multicenter, survey-based study. Patients who applied to the cardiology outpatient clinic with a preliminary diagnosis of HF or were hospitalized for HF and had a diagnosis of HF for at least 6 months will be included in the study.

Description:

ADAPTATION HF is a prospective, observational, cross-sectional, multicenter, survey-based study. Patients who applied to the cardiology outpatient clinic with a preliminary diagnosis of HF or were hospitalized for HF and had a diagnosis of HF for at least 6 months will be included in the study. Data entry staff who will be assigned to the centers for 2 weeks will apply a questionnaire consisting of different questions to the patients referred to them by clinicians with the diagnosis of HF. In addition, Pittsburg Sleep Quality Index will be applied to all cases. In addition, clinical features of HF from the current file of the cases (NYHA, comorbid conditions, comorbid diseases, blood pressure, heart rate, last drugs used, latest biochemistry (BNP/NTproBNP if available), hematology test results, most recent ECG , most recent echocardiography, coronary angiography report, if available) 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 500 patients from 10 centers will be included in this study over a six-month period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatient or inpatient diagnosed with Heart Failure at least 6 months ago

• Male or female patient aged 18 and over

• Signed written informed consent form

Exclusion Criteria:

• newly diagnosed heart failure

• CRY requiring dialysis

• Serious liver and lung disease

• LVAD/heart transplantation

• HF due to possible temporary cause (myocarditis, peripartum CMP in the first 6 months, takotsubo etc.)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Questionnaies
Data entry staff who will be assigned to the centers for 2 weeks will apply a questionnaire consisting of different questions to the patients referred to them by clinicians with the diagnosis of HF (presented in the appendix to this protocol). In addition, Pittsburg Sleep Quality Index will be applied to all cases.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Eskisehir Osmangazi University Medical Faculty	Eskisehir
Turkey	Baskent University Istanbul Health Practice and Research Center Hospital	Istanbul
Turkey	Dr. Siyami Ersek Chest Cardiac and Vascular Surgery T&R Hospital	Istanbul
Turkey	Istanbul University - Cerrahpasa, Cardiology Institute	Istanbul
Turkey	Dokuz Eylül University Medical Faculty	Izmir
Turkey	Ege University Medical Faculty	Izmir
Turkey	Tepecik Training and Research Hospital	Izmir
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	General Status of the patients	At the end of the six-month recruitment period, demographic, symptoms, clinical follow-up status, disease information, treatment compliance, and awareness assessment will be performed on all included patients.	6 months
Secondary	HF Risk Factors		6 Months
Secondary	HF Percutaneous Intervention History & Operation History		6 Months
Secondary	Medications Used for HF		6 Months
Secondary	HF Comorbidities		6 Months
Secondary	HF ECHO Results		6 Months
Secondary	HF Laboratory Results		6 Months