ClinicalTrials.gg
Active, not recruitingNCT07469137Updated Mar 13, 2026

THE RELATIONSHIP BETWEEN CARDIAC RESYNCHRONİZATION THERAPY RESPONSE IN HEART FAILURE PATIENTS AND YKL-40 LEVELS

An observational study in Hearth Failure With Reduced Ejection Fraction (HFrEF), Cardiac Resynchronisation Therapy (CRT) and Left Branch Bundle Block, sponsored by Trakya University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Trakya University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
51
Ages
18 Years and older
Sex
All
01

Study summary

Patients diagnosed with heart failure at our clinic who routinely undergo CRT implantation will be included in the study. This decision is independent of the study. In patients included in the study, after routine placement of a coronary sinus catheter, 2 cc of blood will be drawn from this catheter without performing any additional invasive procedures on the patient. Additionally, one peripheral blood sample will be collected from the patient's routinely accessed antebrachial vein. The blood samples will be centrifuged at 4000 rpm (revolutions per minute) for 10 minutes to separate the serum and stored at -80 °C until analyzed. The demographic, clinical, laboratory, electrocardiographic, and echocardiographic data of these patients will be recorded. At the 6-month follow-up clinic visit after discharge, routine heart failure parameters, routine echocardiographic data, and routine ECG recordings will be obtained. The procedures to be performed after discharge are routine for patients who have undergone CRT implantation at our clinic, and no additional follow-up or tests will be performed for this study. After all data are recorded, statistical evaluation will be performed. Data will be reviewed through the ENLİL HBYS system. The best criteria for determining CRT response have not been clearly established. Many studies have been conducted to predict CRT response in advance. A review of the literature shows that YKL-40 levels in the blood are associated with cardiovascular diseases, but no study in the literature has shown the relationship between YKL-40 levels and CRT implantation in patients.

Read the detailed description

Patients diagnosed with heart failure who are under follow-up and have an EF \<35 despite optimal medical treatment, and whose functional capacity is 2-3, or patients diagnosed with heart failure who routinely undergo CRT implantation at our clinic due to high-degree block will be included in the study. This decision was made independently of the study. Patients routinely undergo permanent pacemaker implantation with leads placed in the right ventricle, coronary sinus, and right atrium. In patients included in the study, after routine placement of the coronary sinus catheter, 2 cc of blood will be drawn from this catheter without performing any additional invasive procedures on the patient. In addition, one peripheral blood sample will be drawn from the patient's routinely opened antebrachial vein. The blood samples will be centrifuged at 4000 rpm (revolutions per minute) for 10 minutes to separate the serum and stored at -80 °C until analyzed. The demographic, clinical, laboratory, electrocardiographic, and echocardiographic data of these patients will be recorded. At the 6-month follow-up clinic visit after discharge, routine heart failure parameters, routine echocardiographic data, and routine ECG recordings will be obtained. The procedures to be performed after discharge are routine for patients who have undergone CRT implantation at our clinic, and no additional follow-up or tests will be performed for this study. After all data are recorded, statistical evaluation will be performed. Data will be reviewed via the ENLİL HBYS system. In the literature, patients with KRT are grouped as RESPONDERS and NON-RESPONDERS. Although the best criteria for determining KRT response have not been clearly established, three categories can be considered in the evaluation. The first is clinical measurements (New York Heart Association classification, functional capacity, etc.), the second is the assessment of left ventricular reverse remodeling (increase in ejection fraction on echocardiography, decrease in left ventricular end-systolic and end-diastolic volume), and the third is the reduction in heart failure-related hospitalization and all-cause mortality during follow-up. In addition, individual factors may also influence the outcome. These factors include genetic and gender differences, left ventricular lead position, left ventricular scarring in ischemic patients, and atrial fibrillation. Patients who are NON RESPONDERS are less likely to benefit from CRT, which is an undesirable outcome for invasive treatment. Patients with pacemakers are at risk for foreign body infection and infective endocarditis, and the presence of a device that does not enhance cardiac function is undesirable. Many studies have been conducted to predict the response to CRT. Reviewing the literature, it has been shown that YKL-40 levels in the blood are associated with cardiovascular diseases; however, no study in the literature has shown the relationship between YKL-40 levels and cardiac resynchronization therapy implantation in patients.

02

Conditions studied

  • Hearth Failure With Reduced Ejection Fraction (HFrEF)
  • Cardiac Resynchronisation Therapy (CRT)
  • Left Branch Bundle Block

Keywords

  • heart failure
  • cardiac resynchronisation therapy
  • left branch bundle block
  • reduced ejection fraction
  • ykl-40
  • CHI3L1
03

In context

Bundle-Branch Block

94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.

This study's enrollment of 51 is below the median of 162 across 33 observational studies indexed under Bundle-Branch Block.

Browse Bundle-Branch Block studies →

Lead sponsor

Trakya University is the lead sponsor of 155 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with heart failure who have been decided to undergo CRT treatment at Trakya University Cardiology Clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with heart failure, with an EF ≤35, who remain in heart failure stages 2-3-4 despite optimal medical therapy, and who have LBBB and a QRS duration of at least 130 msec.
  • Those who agreed to participate in the study
  • Patients diagnosed with heart failure and who have been monitored, and for whom a permanent pacemaker has been decided due to the presence of a high-degree heart block

Exclusion criteria

Exclusion Criteria:

  • Patients under the age of 18
  • Patients not receiving optimal medical treatment
  • Those who declined to participate in the study
  • patients with an expected survival period of less than 1 year
  • Patients with chronic inflammatory and rheumatological diseases
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
51 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. The relationship between YKL-40 levels measured in patients undergoing CRT and their CRT response at 6-month follow-up

    Serum YKL-40 levels measured during cardiac resynchronization therapy (CRT) will be evaluated in conjunction with the CRT response during the patient's routine 6-month follow-up after the procedure. Patients are those for whom the decision to undergo the procedure was made independently of the study. Follow-ups are routine; there is no additional follow-up for the study.

    Time frame: Baseline and 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07469137
Lead sponsor
Trakya University
Responsible party
Furkan Karahan (Resident Doctor, Trakya University) — Principal investigator
First posted
Mar 13, 2026
Start date
Mar 1, 2025
Primary completion
Jun 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Mar 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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