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CompletedNCT05180370ADAPTATION-HFUpdated Feb 23, 2023

Multicenter Prospective Observational Study Evaluating the Management of Heart Failure

An observational study in Heart Failure, sponsored by AstraZeneca Turkey. Completed at 10 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by AstraZeneca Turkey · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Heart Failure
  • Questionnaire
  • ECHO
  • Prospective
  • Cross-Sectional
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherQuestionnaies

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. HF Risk Factors

    Time frame: 6 Months

  2. HF Percutaneous Intervention History & Operation History

    Time frame: 6 Months

  3. Medications Used for HF

    Time frame: 6 Months

  4. HF Comorbidities

    Time frame: 6 Months

  5. HF ECHO Results

    Time frame: 6 Months

  6. HF Laboratory Results

    Time frame: 6 Months

06

Study locations

10 sites
  • Ankara City Hospital
    Ankara, Turkey
  • Akdeniz University Medical Faculty
    Antalya, Turkey
  • Eskişehir Osmangazi University Medical Faculty
    Eskişehir, 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
    Istanbul, Turkey
  • Dokuz Eylül University Medical Faculty
    İzmir, Turkey
  • Ege University Medical Faculty
    İzmir, Turkey
  • Tepecik Training and Research Hospital
    İzmir, Turkey
  • Mersin University Medical Faculty
    Mersin, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05180370
Lead sponsor
AstraZeneca Turkey
Collaborators
Klinar CRO
Responsible party
Sponsor
First posted
Jan 6, 2022
Start date
Mar 15, 2021
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022
Last update
Feb 23, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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