Coronary blood flow testing in people with reduced ejection fraction and left bundle branch block after CRT
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
This work will test whether direct intracoronary measurements of flow and pressure show reduced coronary blood flow in people with low ejection fraction and left bundle branch block who have a CRT device.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT05564689 on ClinicalTrials.gov |
What this trial studies
This observational protocol collects invasive intracoronary flow and pressure measurements (absolute coronary flow and pressure-derived indices) in patients with non-ischemic dilated cardiomyopathy, left bundle branch block, and an implanted CRT device. Measurements focus on the left anterior descending artery and other target vessels to quantify regional blood flow and diastolic flow characteristics. Eligible participants are adults in sinus rhythm with QRS ≥150 ms on stable medical therapy, while patients with ischemic heart disease, prior MI or revascularization, permanent atrial fibrillation, severe valvular disease, or eGFR <30 ml/min are excluded. The investigators will relate flow patterns to ventricular activation and CRT status to explore mechanisms that might explain why some CRT recipients do not improve.
Who should consider this trial
Good fit: Adults with non-ischemic dilated cardiomyopathy, left bundle branch block, sinus rhythm, QRS ≥150 ms, stable medical therapy, and an implanted CRT device who can give informed consent in Danish are ideal candidates.
Not a fit: People with heart failure from ischemic disease, prior myocardial infarction or coronary revascularization, permanent atrial fibrillation, severe valvular disease, eGFR <30 ml/min, another implanted device type, or who cannot consent or understand Danish would not be eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the findings could clarify why some CRT recipients fail to improve and help guide better patient selection or device optimization to improve outcomes.
How similar studies have performed: Prior echocardiography and perfusion studies have suggested regional flow and metabolic abnormalities in LBBB and links to CRT response, but direct intracoronary absolute flow measurements in this population are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 * QRS ≥ 150 ms before implantation * Heart failure because of dilated cardiomypathy * Sinus rhythm * Stable medical therapy * LBBB * CRT device Exclusion Criteria: * eGFR \< 30 ml/min * Severe valvular heart disease * Permanent atrial fibrillation or atrial flutter * Prior PCI or CABG * Prior myocardial infarction * Heart failure due to ischemic heart disease * Other type of device (pacemaker, ICD) * Not able to give informed consent * Does not understand Danish
Where this trial is running
Aalborg
- Aalborg Universityhospital — Aalborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Ashkan Eftekhari — Department of Cardiology, Aalborg University Hospital
- Study coordinator: Ashkan Eftekhari
- Email: asef@rn.dk
- Phone: 004528973764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.