Heart FailureADAPTATION-HFNCT05180370
Multicenter Prospective Observational Study Evaluating the Management of Heart Failure
An observational study of Heart Failure, run by AstraZeneca Turkey at 10 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Questionnaies
- How many people
- 500 participants
- Where
- 10 sitesTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Turkey (Türkiye)10 sites
Ankara City Hospital
Ankara
Akdeniz University Medical Faculty
Antalya
Eskişehir Osmangazi University Medical Faculty
Eskişehir
Başkent University Istanbul Health Practice and Research Center Hospital
Istanbul
Dr. Siyami Ersek Chest Cardiac and Vascular Surgery T&R Hospital
Istanbul
Istanbul University - Cerrahpaşa, Cardiology Institute
Istanbul
Dokuz Eylül University Medical Faculty
Izmir
Ege University Medical Faculty
Izmir
Tepecik Training and Research Hospital
Izmir
Mersin University Medical Faculty
Mersin
About this study
Official title: 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.
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.
- Conditions
- Heart Failure
- Being tested
- Questionnaies
- Keywords
- Heart Failure, Questionnaire, ECHO, Prospective, Cross-Sectional
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
HF Risk Factors
Measured: 6 Months
HF Percutaneous Intervention History & Operation History
Measured: 6 Months
Medications Used for HF
Measured: 6 Months
HF Comorbidities
Measured: 6 Months
HF ECHO Results
Measured: 6 Months
HF Laboratory Results
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start15 Mar 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca Turkey
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Klinar CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180370
- Sponsor's protocol ID
- K-J019
- Acronym
- ADAPTATION-HF
- Status last verified
- Feb 2023
- First submitted
- 3 Sep 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire-based Multicenter Prospective Observational Study Evaluating Patient Perception, Compliance and Adaptation in the Management of Heart Failure - ADAPTATION HF
- ClinicalTrials.gov ID
- NCT05180370
- Acronym / sponsor ID
- ADAPTATION-HF / K-J019
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Questionnaire, ECHO, Prospective, Cross-Sectional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- AstraZeneca TurkeyIndustry (pharma, biotech, devices)
- Collaborators
- Klinar CRO
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient or inpatient diagnosed with Heart Failure at least 6 months ago | – | Other: QuestionnaiesADAPTATION 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaiesData 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. | Other | Outpatient or inpatient diagnosed with Heart Failure at least 6 months ago |
Primary outcome
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.
6 secondary outcomes
HF Risk Factors
Time frame: 6 Months
HF Percutaneous Intervention History & Operation History
Time frame: 6 Months
Medications Used for HF
Time frame: 6 Months
HF Comorbidities
Time frame: 6 Months
HF ECHO Results
Time frame: 6 Months
HF Laboratory Results
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by AstraZeneca Turkey at 10 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Status of the patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.