Multicenter Prospective Observational Study Evaluating the Management of Heart Failure (ADAPTATION-HF)

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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara City Hospital
  • Antalya, Turkey
    • Akdeniz University Medical Faculty
  • Eskişehir, Turkey
    • Eskisehir Osmangazi University Medical Faculty
  • Istanbul, Turkey
    • Başkent 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 - Cerrahpaşa, Cardiology Institute
  • Mersin, Turkey
    • Mersin University Medical Faculty
  • İzmir, Turkey
    • Tepecik Training and Research Hospital
  • İzmir, Turkey
    • Ege University Medical Faculty
  • İzmir, Turkey
    • Dokuz Eylul 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 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Outpatient or inpatient diagnosed with Heart Failure at least 6 months ago; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
HF Risk Factors	6 Months
HF Percutaneous Intervention History & Operation History	6 Months
Medications Used for HF	6 Months
HF Comorbidities	6 Months
HF ECHO Results	6 Months
HF Laboratory Results	6 Months

Collaborators and Investigators

• Sponsor: AstraZeneca Turkey
• Collaborators: Klinar CRO

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

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; Cross-Sectional; Prospective; ECHO
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: K-J019

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