A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved EjectiON Fraction

NCT03026114 | Completed

• 1 other identifier: MuglaSKU
• Study Type: observational
• Target: 1,065
• Locations: 1 country
• Sites: 1

Brief 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%). 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  Recruited and could be analysed at least 1065 patients after 3 months

Interventions

No intervention is planned in our study. OTHER

No intervention is planned in our study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presented to cardiology outpatient clinics with signs and/or symptoms of HF will be screened.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Kahramanmaras Necip Fazıl City Hospital

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32281959 DERIVED

• Ozlek 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.

  PMID: 30446354 DERIVED

• Ozlek 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.

  PMID: 29724973 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• BÜLENT ÖZLEK, M.D.

  Mugla Sitki Kocman University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 20, 2017
• Study Start: March 30, 2018
• Primary Completion: May 20, 2018
• Study Completion: May 20, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)