Heart FailureAWARENESS-HFNCT05180396
A Study on Disease Awareness and Treatment Compliance of Heart Failure Patients
An observational study of Heart Failure, run by AstraZeneca Turkey at 3 sites in Turkey (Türkiye).
Trial summary
The AWARENESS HF-PD is a cross-sectional, multicenter, survey-based study. Cases who were admitted to the outpatient clinic and hospitalized with the diagnosis of Heart Failure (Acute and Chronic) 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?
- Questionnaires
- How many people
- 200 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 12 Mar 2021to 10 Sep 2021
- 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 with the diagnosis of Heart Failure (Acute and Chronic) who were admitted to the outpatient clinic and hospitalized will be included in the study. It is planned to include 200 patients from 3 centers in this study.
Who may be able to join
- Male or female patients aged 18 and over
- Patients diagnosed with acute or chronic heart failure
- Patients who agreed to participate in the study
Who cannot join
- Patients who stated that they did not agree to participate in the study
- Patients who were not diagnosed with Heart Failure or whose diagnosis was changed or not confirmed during the index application
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Akdeniz University Medical Faculty
Antalya
Kahramanmaraş Sütçü İmam University Medical Faculty
Kahramanmaraş
Mersin University Medical Faculty
Mersin
About this study
Official title: A Multicenter, Cross-sectional Study Evaluating the Symptoms, Clinical Follow-ups, Problems Encountered During the Course of the Disease, Disease Awareness and Treatment Compliance of Heart Failure Patients - AWARENESS HF-PD(Patient Diary)
The AWARENESS HF-PD is a cross-sectional, multicenter, survey-based study. Cases who were admitted to the outpatient clinic and hospitalized with the diagnosis of Heart Failure (Acute and Chronic) will be included in the study.
Read the detailed description
Data entry personnel to be assigned at the centers throughout the study will apply a questionnaire consisting of different questions to patients referred to them by clinicians with the diagnosis of HF. In addition, clinical features of HF from the current file of the cases (NYHA, comorbid conditions, comorbid diseases, blood pressure, heart rate, latest biochemistry (BNP/NTproBNP if available), hematology test results, most recent ECG, most recent echocardiography , coronary angiography report, if any) 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 200 patients from 3 centers will be included in this study over a six-month period.
- Conditions
- Heart Failure
- Being tested
- Questionnaires
- Keywords
- Heart Failure, Questionnaire, ECHO, Prospective
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Application of a study based questionnaire described in the protocol
| Study group | Role | What they receive |
|---|---|---|
| Cases with the diagnosis of Heart Failure (Acute and Chronic) | Application of a questionnaire consisting of different questions to patients. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
At the end of the six-month recruitment period, demographic, symptoms, clinical follow-up status, d will be performed on all included patients.
Measured: 6 months
Disease Information
At the end of the six-month recruitment period disease information, treatment compliance, and awareness assessment will be performed on all included patients.
Measured: 6 months
Secondary outcomes (5)
HF Risk Factors (BMI, Diabetes, Hypertension, HLP, Tobbaco Use, CV Hereditary, Menapause, MI History and History of CMP in family)
BMI, Diabetes, Hypertension, HLP, Tobbaco Use, CV Hereditary, Menapause, MI History and History of CMP in family
Measured: 6 months
HF Percutaneous Intervention / Operation History (CRT, ICD, CRT-DI, Pacemaker, PKG, CABG and Heart Valve Operations)
CRT, ICD, CRT-DI, Pacemaker, PKG, CABG and Heart Valve Operations
Measured: 6 months
HF Comorbidities (CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS)
(CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS
Measured: 6 months
HF Laboratory Results (Glucose, BUN, Creatinine, GFR, Sodium, Potassium, Nt-ProBNP, ALT, AST, ALP, HS-CRP, cTN, Hemoglobine, WBC, Ferritine, TSAD, LDL, tryglyceride, ST3, GGT, INR, ST4)
Glucose, BUN, Creatinine, GFR, Sodium, Potassium, Nt-ProBNP, ALT, AST, ALP, HS-CRP, cTN, Hemoglobine, WBC, Ferritine, TSAD, LDL, tryglyceride, ST3, GGT, INR, ST4)
Measured: 6 months
HF ECHO Results (EF, LA, SID, Mitral Defficiency, SPAB, DID, Septum, SEG Muscle Weakness, Trial Defficiency)
(EF, LA, SID, Mitral Defficiency, SPAB, DID, Septum, SEG Muscle Weakness, Trial Defficiency)
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 start12 Mar 2021
- Primary completion30 Jul 2021
- Study completion10 Sep 2021
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
- 200 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
- NCT05180396
- Sponsor's protocol ID
- K-J020
- Acronym
- AWARENESS-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
- A Multicenter, Cross-sectional Study Evaluating the Symptoms, Clinical Follow-ups, Problems Encountered During the Course of the Disease, Disease Awareness and Treatment Compliance of Heart Failure Patients - AWARENESS HF-PD(Patient Diary)
- ClinicalTrials.gov ID
- NCT05180396
- Acronym / sponsor ID
- AWARENESS-HF / K-J020
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Questionnaire, ECHO, Prospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AstraZeneca TurkeyIndustry (pharma, biotech, devices)
- Collaborators
- Klinar CRO
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 10 Sep 2021 (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.
The AWARENESS HF-PD is a cross-sectional, multicenter, survey-based study. Cases who were admitted to the outpatient clinic and hospitalized with the diagnosis of Heart Failure (Acute and Chronic) will be included in the study.
Detailed description
Data entry personnel to be assigned at the centers throughout the study will apply a questionnaire consisting of different questions to patients referred to them by clinicians with the diagnosis of HF. In addition, clinical features of HF from the current file of the cases (NYHA, comorbid conditions, comorbid diseases, blood pressure, heart rate, latest biochemistry (BNP/NTproBNP if available), hematology test results, most recent ECG, most recent echocardiography , coronary angiography report, if any) 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 200 patients from 3 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 |
|---|---|---|
| Cases with the diagnosis of Heart Failure (Acute and Chronic) | – | Other: QuestionnairesApplication of a questionnaire consisting of different questions to patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases with the diagnosis of Heart Failure (Acute and Chronic) who were admitted to the outpatient clinic and hospitalized will be included in the study. It is planned to include 200 patients from 3 centers in this study.
Key inclusion criteria (3 listed)
- Male or female patients aged 18 and over
- Patients diagnosed with acute or chronic heart failure
- Patients who agreed to participate in the study
Key exclusion criteria (3 listed)
- Patients who stated that they did not agree to participate in the study
- Patients who were not diagnosed with Heart Failure or whose diagnosis was changed or not confirmed during the index application
- Pregnancy
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 |
|---|---|---|
| QuestionnairesApplication of a study based questionnaire described in the protocol | Other | Cases with the diagnosis of Heart Failure (Acute and Chronic) |
Primary outcome
Demographics
Time frame: 6 months
At the end of the six-month recruitment period, demographic, symptoms, clinical follow-up status, d will be performed on all included patients.
Disease Information
Time frame: 6 months
At the end of the six-month recruitment period disease information, treatment compliance, and awareness assessment will be performed on all included patients.
5 secondary outcomes
HF Risk Factors (BMI, Diabetes, Hypertension, HLP, Tobbaco Use, CV Hereditary, Menapause, MI History and History of CMP in family)
Time frame: 6 months
HF Percutaneous Intervention / Operation History (CRT, ICD, CRT-DI, Pacemaker, PKG, CABG and Heart Valve Operations)
Time frame: 6 months
HF Comorbidities (CAD, AF, COPD, CRF, Anemia, Iron Defficiency, Hypo- Hypertiroidy, OSAS)
Time frame: 6 months
HF Laboratory Results (Glucose, BUN, Creatinine, GFR, Sodium, Potassium, Nt-ProBNP, ALT, AST, ALP, HS-CRP, cTN, Hemoglobine, WBC, Ferritine, TSAD, LDL, tryglyceride, ST3, GGT, INR, ST4)
Time frame: 6 months
HF ECHO Results (EF, LA, SID, Mitral Defficiency, SPAB, DID, Septum, SEG Muscle Weakness, Trial Defficiency)
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
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
3 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 3 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 3 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 3 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?
Demographics (time frame: 6 months). The study lists 2 primary outcomes in all. 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.