Heart FailureNCT07436377
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
An observational study of Heart Failure and Cardiac Resynchronization Therapy, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Resynchronization Therapy, Coronary Sinus
- What is being tested?
- coronary sinus blood sampling
- Type of treatment
- Injection or infusion
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 Mar 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- Patients diagnosed with heart failure, with an EF <35, and in heart failure stages 2-3-4 despite optimal medical therapy.
- Those who agree to participate in the study.
- Patients aged 18 years and older.
- Patients with a QRS duration of 135 ms or more on ECG.
Who cannot join
- Patients with EF 35 or higher.
- QRS duration on ECG less than 130 milliseconds.
- Not receiving the maximum tolerable dose of medication for KY.
- Absence of left bundle branch block morphology on ECG.
- History of acute myocardial infarction within the last 3 months.
- Estimated life expectancy of less than 1 year.
Show all 12Show fewer
- History of cardiac surgery within the last 3 months.
- Elective cardiac surgery planned.
- Patients scheduled for CRT prior to nodal ablation.
- Patients with intracardiac shunts.
- Those who refuse to participate in the study.
- Chronic lung diseases (COPD, emphysema, bronchitis, etc.). -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Faculty of Medicine Hospital
Edirne, 22100
About this study
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.
- Being tested
- coronary sinus blood sampling
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary sinus blood samplingDiagnostic test
Blood gas analysis by drawing blood from the coronary sinus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: coronary sinus blood sampling | |
| 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. Receives: Diagnostic Test: coronary sinus blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint of hospitalization for heart failure, death, need for IV diuretics, change in ejection fraction, and change in NYHA classification
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 posted27 Feb 2026
- Study start1 Sep 2022
- Primary completion1 Sep 2024
- Study completion15 Mar 2026 (estimated)
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
- 65 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efe Yilmaz, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436377
- Sponsor's protocol ID
- TÜTF-GOBAEK 2022/174
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07436377
- Acronym / sponsor ID
- TÜTF-GOBAEK 2022/174
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group that benefits from CRT | – | Diagnostic Test: coronary sinus blood samplingAt 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. |
| The group that benefits from CRT and the group that does not | – | Diagnostic Test: coronary sinus blood samplingAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patients diagnosed with heart failure, with an EF <35, and in heart failure stages 2-3-4 despite optimal medical therapy.
- Those who agree to participate in the study.
- Patients aged 18 years and older.
- Patients with a QRS duration of 135 ms or more on ECG.
Key exclusion criteria (12 listed)
- Patients with EF 35 or higher.
- QRS duration on ECG less than 130 milliseconds.
- Not receiving the maximum tolerable dose of medication for KY.
- Absence of left bundle branch block morphology on ECG.
- History of acute myocardial infarction within the last 3 months.
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 |
|---|---|---|
| coronary sinus blood samplingBlood gas analysis by drawing blood from the coronary sinus | Diagnostic test | The group that benefits from CRT, The group that benefits from CRT and the group that does not |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Cardiac Resynchronization Therapy, run by Trakya 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 4 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
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). 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 27 Feb 2026.