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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05180370
Other study ID # K-J019
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.)

Study Design


Related Conditions & MeSH terms


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
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