NCT05564689 Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
| NCT ID | NCT05564689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ashkan Eftekhari |
| Condition | Left Bundle-Branch Block |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-09-29 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-09-29 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cardiac resynchronization therapy (CRT) is an effective therapeutic strategy in patients with symptomatic heart failure (HF) patients with LVEF of ≤35% and left bundle branch block (LBBB). However, approximately one-third of CRT-recipients do not improve after therapy (non-responders), despite meeting the required criteria. Previous studies have documented that the positive respons to CRT is related to the delayed electrical activation of the left ventricle in patients with LBBB. It has also been illustrated that non-ischemic CRT-candidates with LBBB demonstrate lower regional myocardial blood flow and metabolism in the septum. Additionally, it has been suggested that LBBB can lead to impaired coronary blood flow in the left anterior descending artery (LAD). This observation is based on an echocardiography-based study, that showed that the percentage of diastolic flow duration (%DD) in LAD was shorter in patients with LBBB compared to the control-group and patients with right-ventricular pacing. It has been demonstrated that CRT has positive effects on septal myocardial perfusion in patients with HF and LBBB. The dominant hypothesis explaining this phenomenon is built on improved septal myocardial work after CRT-implantation, which leads to increased myocardial energy and therefore increased myocardial perfusion. In contrast, it has been suggested that due to re-established synchronous left ventricular electrical activation, CRT reduces the septal intramyocardial pressure in early diastole, leading to a relatively longer antegrade flow duration in LAD. Therefore, the aim of the study is to evaluate the effect of CRT on coronary blood flow in LAD in patients with non-ischemic HF and LBBB. The investigators hypothesize that increased LV-function after CRT not only is due to resynchronized LV ejection and filling, but also improved coronary flow. The study aims to enroll 60 patients with heart failure due to non-ischemic dilated cardiomyopathy, LBBB, with or without CRT. All patients meeting the criteria will be recruited from the outpatient clinic at the Department of Cardiology, Aalborg University Hospital. Invasive flow measurements in the LAD, including fractional flow reserve (FFR), absolute coronary flow and -reserve will be conducted with the CRT on and off, respectively.
Eligibility 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
Contact & Investigator
Ashkan Eftekhari
PRINCIPAL INVESTIGATOR
Department of Cardiology, Aalborg University Hospital
Frequently Asked Questions
Who can join the NCT05564689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Left Bundle-Branch Block. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05564689 currently recruiting?
Yes, NCT05564689 is actively recruiting participants. Contact the research team at asef@rn.dk for enrollment information.
Where is the NCT05564689 trial being conducted?
This trial is being conducted at Aalborg, Denmark.
Who is sponsoring the NCT05564689 clinical trial?
NCT05564689 is sponsored by Ashkan Eftekhari. The principal investigator is Ashkan Eftekhari at Department of Cardiology, Aalborg University Hospital. The trial plans to enroll 60 participants.