Clinical trial NCT05180370: Multicenter Prospective Observational Study Evaluating the Management of Heart Failure
Official title: Questionnaire-based Multicenter Prospective Observational Study Evaluating Patient Perception, Compliance and Adaptation in the Management of Heart Failure - ADAPTATION HF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Questionnaire
ECHO
Prospective
Cross-Sectional
Lead sponsor: AstraZeneca Turkey
Sponsor class: INDUSTRY
Collaborators: name: Klinar CRO
First posted: 2022-01-06
Enrollment: 500
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 admitted to the cardiology outpatient clinic or hospitalized for Heart Failure and diagnosed with HF for at least 6 months will be included in the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: General Status of the patients
timeFrame: 6 months
Secondary outcomes:
measure: HF Risk Factors
timeFrame: 6 Months
measure: HF Percutaneous Intervention History & Operation History
timeFrame: 6 Months
measure: Medications Used for HF
timeFrame: 6 Months
measure: HF Comorbidities
timeFrame: 6 Months
measure: HF ECHO Results
timeFrame: 6 Months
measure: HF Laboratory Results
timeFrame: 6 Months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University Medical Faculty
city: Istanbul
country: Turkey
facility: Başkent University Istanbul Health Practice and Research Center Hospital
city: Istanbul
country: Turkey
facility: Dr. Siyami Ersek Chest Cardiac and Vascular Surgery T&R Hospital
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpaşa, Cardiology Institute
city: İzmir
country: Turkey
facility: Dokuz Eylül University Medical Faculty
city: İzmir
country: Turkey
facility: Ege University Medical Faculty
city: İzmir
country: Turkey
facility: Tepecik Training and Research Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
Study officials:
References: