THE RELATİONSHİP BETWEEN BLOOD GAS PARAMETERS OBTAİNED FROM THE CORONARY SİNUS DURİNG THE PROCEDURE AND CRT RESPONSE İN PATİENTS WİTH HEART FAİLURE WHO UNDERWENT CRT IMPLANTATİON

February 20, 2026 updated by: Efe Yilmaz, Trakya University
Heart failure (HF) is one of the clinical syndromes with the highest morbidity and mortality rates among cardiovascular diseases. Despite pharmacological treatments, symptoms persist in a significant proportion of patients, and mortality cannot be prevented. Therefore, device-based therapies, particularly cardiac resynchronisation therapy (CRT), have gained an important place in the treatment algorithm.CRT aims to correct mechanical dyssynchrony by enabling simultaneous contraction of the left and right ventricles. It also aims to reduce sudden cardiac death rates with its defibrillator feature. Current guidelines emphasise that CRT provides significant benefits in terms of symptomatic improvement and long-term survival when appropriate patient selection is made. However, not all patients who meet the criteria have benefited equally from CRT. It is difficult to predict in advance which heart failure patients will benefit from CRT.The aim of the study is to analyse blood gas parameters obtained from the coronary sinus during the procedure in cases of symptomatic heart failure with low ejection fraction despite optimal medical treatment and in patients with indications for CRT according to current guidelines. This analysis aims to contribute to the prior identification of patients who may benefit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Edirne, Turkey (Türkiye), 22100
        • Trakya University Faculty of Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Heart failure patients with an ejection fraction below 35, NYHA physical capacity of 2-3, and QRS duration longer than 135 ms on ECG, whose symptoms persist despite optimal medical treatment.

Description

Inclusion Criteria:

  1. Patients diagnosed with heart failure, with an EF <35, and in heart failure stages 2-3-4 despite optimal medical therapy.
  2. Those who agree to participate in the study.
  3. Patients aged 18 years and older.
  4. Patients with a QRS duration of 135 ms or more on ECG.

Exclusion Criteria:

  1. Patients with EF 35 or higher.
  2. QRS duration on ECG less than 130 milliseconds.
  3. Not receiving the maximum tolerable dose of medication for KY.
  4. Absence of left bundle branch block morphology on ECG.
  5. History of acute myocardial infarction within the last 3 months.
  6. Estimated life expectancy of less than 1 year.
  7. History of cardiac surgery within the last 3 months.
  8. Elective cardiac surgery planned.
  9. Patients scheduled for CRT prior to nodal ablation.
  10. Patients with intracardiac shunts.
  11. Those who refuse to participate in the study.
  12. Chronic lung diseases (COPD, emphysema, bronchitis, etc.). -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The group that benefits from CRT
At the sixth-month visit, patients' ECG findings, NYHA classification, echocardiography parameters, history of hospitalization due to heart failure, need for intravenous (IV) diuretic therapy, need for diuretic dose increase, mortality, device pacing, and intensive care unit admission were evaluated. At the end of follow-up, patients who showed at least a 5-point or 15% increase in ejection fraction and at least a one-grade improvement in NYHA class, and who did not develop heart failure-related death, hospitalization, or IV diuretic requirement during the same period, were classified as the "responsive" group to CRT treatment. Other patients were classified as the "non-responsive" group.
Diagnostic test: coronary sinus blood sampling
Blood gas analysis by drawing blood from the coronary sinus
The group that benefits from CRT and the group that does not
At the sixth-month visit, patients' ECG findings, NYHA classification, echocardiography parameters, history of hospitalization due to heart failure, need for intravenous (IV) diuretic therapy, need for diuretic dose increase, mortality, device pacing, and intensive care unit admission were evaluated. At the end of follow-up, patients who showed at least a 5-point or 15% increase in ejection fraction and at least a one-grade improvement in NYHA class, and who did not develop heart failure-related death, hospitalization, or IV diuretic requirement during the same period, were classified as the "responsive" group to CRT treatment. Other patients were classified as the "non-responsive" group.
Diagnostic test: coronary sinus blood sampling
Blood gas analysis by drawing blood from the coronary sinus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Combined endpoint of hospitalization for heart failure, death, need for IV diuretics, change in ejection fraction, and change in NYHA classification
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trakya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TÜTF-GOBAEK 2022/174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual patient data will be added to the data system with the written consent of the patients and will be destroyed after statistical analysis. Other researchers are not involved in this process; therefore, these data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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