Heart FailureAPOLLONNCT03026114
A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved EjectiON Fraction
An observational study of Heart Failure, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%), termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or preserved ejection fraction (HFpEF, EF ≥ 50%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 1,065 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2018to 20 May 2018
- How long will I take part?
- 1 Day
- 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: Patients presented to cardiology outpatient clinics with signs and/or symptoms of HF will be screened.
Who may be able to join
- Presentation to the hospital with clinical signs and symptoms of HF, according to the Framingham criteria.
- Age≥ 18 years
- BNP≥35 pg/ml and/or NT-proBNP≥125 pg/ml
Who cannot join
- Pregnancy
- <18 years old
- LVEF < %40
- Cor pulmonale
- Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction;
- Primary hemodynamically significant uncorrected valvular heart disease, prosthetic valve disease
Show all 12Show fewer
- Myocardial infarction in past 90 days
- Coronary artery bypass graft surgery in past 90 days
- Percutaneous coronary intervention in past 30 days;
- Heart transplant recipient;
- Currently implanted left ventricular assist device;
- Stroke in past 90 days;
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Necip Fazıl City Hospital
Kahramanmaraş, 46000
About this study
About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%), termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or preserved ejection fraction (HFpEF, EF ≥ 50%).
Up to now, there are no large scale studies evaluating patients with HFmrEF and/or HFpEF in Turkey. Scarce data are available in the middle-east populations in general and Turkish patients in particular, who have different etiology, ethnic, cultural backgrounds and risk factors from those patients in the West. The aim of this study was to study Turkish patients with HFmrEF and HFpEF, and define their clinical characteristics and the signs and symptoms of heart failure, echocardiographic findings and medications at admission. With this national study, we will evaluate how recommendations of most recent European guidelines regarding pharmacological and non-pharmacological treatments are adopted in clinical practice. We will also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF, according to the definitions proposed by the European Society of Cardiology, and to investigate their appropriateness in characterizing patients with different clinical presentations and needs.
Assessed outcomes included the causes of decompensation, use of medications, care quality indicators.
Read the detailed description
Purpose:
To describe the demographic, clinical, and echocardiographic characteristics and management of outpatients heart failure (HF) with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) followed by a representative setting of cardiology centres.
Background:
About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%), termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or preserved ejection fraction (HFpEF, EF ≥ 50%). Presentation and pathophysiology of HFmrEF and HFpEF is heterogeneous and its management remains a challenge since evidence of therapeutic benefits on outcome is scarce. Up to now, there are no large scale studies evaluating patients with HFmrEF and/or HFpEF in Turkey.
Objective:
Several studies have been conducted in western countries differentiating features of epidemiology, treatment, and outcomes among patients with preserved and reduced EF. Scarce data are available in the middle-east populations in general and Turkish patients in particular, who have different etiology, ethnic, cultural backgrounds and risk factors from those patients in the West. The aim of this study was to study Turkish patients with HFmrEF and HFpEF, and define their clinical characteristics and the signs and symptoms of heart failure, echocardiographic findings and medications at admission. With this national study, we will evaluate how recommendations of most recent European guidelines regarding pharmacological and non-pharmacological treatments are adopted in clinical practice. We will also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF, according to the definitions proposed by the European Society of Cardiology, and to investigate their appropriateness in characterizing patients with different clinical presentations and needs.
Methods:
We have designed a prospective, multicentre, national, observational study to characterize HFmrEF and HFpEF. Patients presented to cardiology outpatient clinics with signs and/or symptoms of HFmrEF and HFpEF will be screened. The eligibility criteria included patients older than 18 years with signs and/or symptoms of HF, admitted to public or private hospitals. Assessed outcomes included the causes of decompensation, use of medications, care quality indicators.
Data:
Clinical data, including the medical history, cardiovascular risk factors, and associate comorbidities, will be collected. The symptoms of patients will be graded according to NYHA classification. Blood samples will be collected for analysis of NT-pro-BNP and /or BNP, and complete laboratory investigations will performed as well. A 12-lead surface ECG will be recorded at 25 mm/s speed. Interpretation will be performed by a skilled investigator, and left ventricular hypertrophy (LVH) will considered according to Sokolow index.
Diastolic function parameters will be measured as follows: peak early diastolic filling (E) and late diastolic filling (A) velocities, E/A ratio, E deceleration time, early diastolic septal mitral annular velocity (e') (averaged from three cardiac cycles), and E/e' as an index of LV filling pressure. Left atrial volume index was calculated from apical four-and two-chamber views, using area - length formula. Diastolic dysfunction will be classified into four grades according to 2009 ASE guidelines.
Conclusion:
A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved EjectiON Fraction (APOLLON) study aims to characterize baseline characteristics of patients with HFmrEF and HFpEF in Turkey.
- Conditions
- Heart Failure
- Being tested
- No intervention is planned in our study.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is planned in our study.Other
No intervention is planned in our study.
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence and management strategies of heart failure with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) patients among participating cardiology outpatient clinics.
Outcomes included the causes of decompensation, use of medications, care quality indicators.
Measured: Recruited and could be analysed at least 1065 patients after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start30 Mar 2018
- Primary completion20 May 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,065 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BÜLENT ÖZLEK, Muğla Sıtkı Koçman University
- Investigators
- BÜLENT ÖZLEK, M.D., Principal investigator, Mugla Sitki Kocman University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026114
- Sponsor's protocol ID
- MuglaSKU
- Acronym
- APOLLON
- Status last verified
- Jun 2018
- First submitted
- 10 Jan 2017
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozlek B, Ozlek E, Tekinalp M, Kahraman S, Zencirkiran Agus H, Basaran O, Kaya BC, Rencuzogullari I, Mert KU, Cakir O, Osken A, Bekar L, Celik Y, Cil C, Dogan V, Celik O, Mert GO, Memic Sancar K, Sevinc S, Biteker M. Comparison of clinical characteristics of patients with heart failure and preserved ejection fraction with atrial fibrillation versus sinus rhythm: Insights from the APOLLON registry. Turk Kardiyol Dern Ars. 2020 Apr;48(3):234-245. doi: 10.5543/tkda.2019.77236.
PubMed 32281959Ozlek B, Ozlek E, Agus HZ, Tekinalp M, Kahraman S, Cil C, Celik O, Basaran O, Dogan V, Kaya BC, Rencuzogullari I, Osken A, Bekar L, Cakir MO, Celik Y, Mert KU, Sancar KM, Sevinc S, Mert GO, Biteker M. Patients with HFpEF and HFmrEF have different clinical characteristics in Turkey: A multicenter observational study. Eur J Intern Med. 2019 Mar;61:88-95. doi: 10.1016/j.ejim.2018.11.001. Epub 2018 Nov 13.
PubMed 30446354Ozlek B, Ozlek E, Celik O, Cil C, Dogan V, Tekinalp M, Zencirkiran Agus H, Kahraman S, Osken A, Rencuzogullari I, Tanik VO, Bekar L, Cakir MO, Kaya BC, Tibilli H, Celik Y, Basaran O, Mert KU, Sevinc S, Demirci E, Dondurmaci E, Biteker M. Rationale, Design, and Methodology of the APOLLON trial: A comPrehensive, ObservationaL registry of heart faiLure with midrange and preserved ejectiON fraction. Anatol J Cardiol. 2018 May;19(5):311-318. doi: 10.14744/AnatolJCardiol.2018.95595.
PubMed 29724973
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved EjectiON Fraction
- ClinicalTrials.gov ID
- NCT03026114
- Acronym / sponsor ID
- APOLLON / MuglaSKU
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,065 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 20 Jan 2017 (estimated)
- 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.
About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%), termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or preserved ejection fraction (HFpEF, EF ≥ 50%).
Up to now, there are no large scale studies evaluating patients with HFmrEF and/or HFpEF in Turkey. Scarce data are available in the middle-east populations in general and Turkish patients in particular, who have different etiology, ethnic, cultural backgrounds and risk factors from those patients in the West. The aim of this study was to study Turkish patients with HFmrEF and HFpEF, and define their clinical characteristics and the signs and symptoms of heart failure, echocardiographic findings and medications at admission. With this national study, we will evaluate how recommendations of most recent European guidelines regarding pharmacological and non-pharmacological treatments are adopted in clinical practice. We will also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF, according to the definitions proposed by the European Society of Cardiology, and to investigate their appropriateness in characterizing patients with different clinical presentations and needs.
Assessed outcomes included the causes of decompensation, use of medications, care quality indicators.
Detailed description
Purpose:
To describe the demographic, clinical, and echocardiographic characteristics and management of outpatients heart failure (HF) with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) followed by a representative setting of cardiology centres.
Background:
About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%), termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or preserved ejection fraction (HFpEF, EF ≥ 50%). Presentation and pathophysiology of HFmrEF and HFpEF is heterogeneous and its management remains a challenge since evidence of therapeutic benefits on outcome is scarce. Up to now, there are no large scale studies evaluating patients with HFmrEF and/or HFpEF in Turkey.
Objective:
Several studies have been conducted in western countries differentiating features of epidemiology, treatment, and outcomes among patients with preserved and reduced EF. Scarce data are available in the middle-east populations in general and Turkish patients in particular, who have different etiology, ethnic, cultural backgrounds and risk factors from those patients in the West. The aim of this study was to study Turkish patients with HFmrEF and HFpEF, and define their clinical characteristics and the signs and symptoms of heart failure, echocardiographic findings and medications at admission. With this national study, we will evaluate how recommendations of most recent European guidelines regarding pharmacological and non-pharmacological treatments are adopted in clinical practice. We will also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF, according to the definitions proposed by the European Society of Cardiology, and to investigate their appropriateness in characterizing patients with different clinical presentations and needs.
Methods:
We have designed a prospective, multicentre, national, observational study to characterize HFmrEF and HFpEF. Patients presented to cardiology outpatient clinics with signs and/or symptoms of HFmrEF and HFpEF will be screened. The eligibility criteria included patients older than 18 years with signs and/or symptoms of HF, admitted to public or private hospitals. Assessed outcomes included the causes of decompensation, use of medications, care quality indicators.
Data:
Clinical data, including the medical history, cardiovascular risk factors, and associate comorbidities, will be collected. The symptoms of patients will be graded according to NYHA classification. Blood samples will be collected for analysis of NT-pro-BNP and /or BNP, and complete laboratory investigations will performed as well. A 12-lead surface ECG will be recorded at 25 mm/s speed. Interpretation will be performed by a skilled investigator, and left ventricular hypertrophy (LVH) will considered according to Sokolow index.
Diastolic function parameters will be measured as follows: peak early diastolic filling (E) and late diastolic filling (A) velocities, E/A ratio, E deceleration time, early diastolic septal mitral annular velocity (e') (averaged from three cardiac cycles), and E/e' as an index of LV filling pressure. Left atrial volume index was calculated from apical four-and two-chamber views, using area - length formula. Diastolic dysfunction will be classified into four grades according to 2009 ASE guidelines.
Conclusion:
A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved EjectiON Fraction (APOLLON) study aims to characterize baseline characteristics of patients with HFmrEF and HFpEF in Turkey.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented to cardiology outpatient clinics with signs and/or symptoms of HF will be screened.
Key inclusion criteria (3 listed)
- Presentation to the hospital with clinical signs and symptoms of HF, according to the Framingham criteria.
- Age≥ 18 years
- BNP≥35 pg/ml and/or NT-proBNP≥125 pg/ml
Key exclusion criteria (12 listed)
- Pregnancy
- <18 years old
- LVEF < %40
- Cor pulmonale
- Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction;
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 |
|---|---|---|
| No intervention is planned in our study.No intervention is planned in our study. | Other | – |
Primary outcome
The prevalence and management strategies of heart failure with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) patients among participating cardiology outpatient clinics.
Time frame: Recruited and could be analysed at least 1065 patients after 3 months
Outcomes included the causes of decompensation, use of medications, care quality indicators.
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 14 Jun 2018.
- Derived from this study: PubMed 32281959Ozlek B, Ozlek E, Tekinalp M, Kahraman S, Zencirkiran Agus H, Basaran O, Kaya BC, Rencuzogullari I, Mert KU, Cakir O, Osken A, Bekar L, Celik Y, Cil C, Dogan V, Celik O, Mert GO, Memic Sancar K, Sevinc S, Biteker M. Comparison of clinical characteristics of patients with heart failure and preserved ejection fraction with atrial fibrillation versus sinus rhythm: Insights from the APOLLON registry. Turk Kardiyol Dern Ars. 2020 Apr;48(3):234-245. doi: 10.5543/tkda.2019.77236.
- Derived from this study: PubMed 30446354Ozlek B, Ozlek E, Agus HZ, Tekinalp M, Kahraman S, Cil C, Celik O, Basaran O, Dogan V, Kaya BC, Rencuzogullari I, Osken A, Bekar L, Cakir MO, Celik Y, Mert KU, Sancar KM, Sevinc S, Mert GO, Biteker M. Patients with HFpEF and HFmrEF have different clinical characteristics in Turkey: A multicenter observational study. Eur J Intern Med. 2019 Mar;61:88-95. doi: 10.1016/j.ejim.2018.11.001. Epub 2018 Nov 13.
- Derived from this study: PubMed 29724973Ozlek B, Ozlek E, Celik O, Cil C, Dogan V, Tekinalp M, Zencirkiran Agus H, Kahraman S, Osken A, Rencuzogullari I, Tanik VO, Bekar L, Cakir MO, Kaya BC, Tibilli H, Celik Y, Basaran O, Mert KU, Sevinc S, Demirci E, Dondurmaci E, Biteker M. Rationale, Design, and Methodology of the APOLLON trial: A comPrehensive, ObservationaL registry of heart faiLure with midrange and preserved ejectiON fraction. Anatol J Cardiol. 2018 May;19(5):311-318. doi: 10.14744/AnatolJCardiol.2018.95595.
- 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.
BÜLENT ÖZLEK, M.D. principal investigator
Mugla Sitki Kocman University Training and Research Hospital
1 site 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 Muğla Sıtkı Koçman University at 1 site 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 12 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 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The prevalence and management strategies of heart failure with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) patients among participating cardiology outpatient clinics. (time frame: Recruited and could be analysed at least 1065 patients after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03026114, which also lists 3 linked publications.
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 14 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.