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Completed

NCT Number: NCT05180370

Multicenter Prospective Observational Study Evaluating the Management of Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Questionnaies

Other

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.

Primary outcomes

  1. General Status of the patients

    Time frame: 6 months

    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.

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

Sponsors and collaborators

Lead sponsor

AstraZeneca Turkey

Industry

Collaborators

  • Klinar CRO

Registry information

Official study title

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

Acronym: ADAPTATION-HF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2022
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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