Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAshkan Eftekhari

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age > 18

QRS ≥ 150 ms before implantation

Heart failure because of dilated cardiomypathy

Sinus rhythm

Disqualifiers

eGFR < 30 ml/min

Severe valvular heart disease

Permanent atrial fibrillation or atrial flutter

Prior PCI or CABG

Trial population

The study will include patients with heart failure due to non ischemic dilated cardiomyopathy and LBBB, with or without excisting CRT. Eligible patients who are admitted to the Department of Cardiology or at a visit to the outpatient clinic at the Dept. Cardiology Aalborg University Hospital will be enrolled in the study.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • Intracoronary flow and pressure

    Procedure/Surgery

    Measurement of absolute coronary flow and resistance

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with or in need of CRT, left bundle branch block, without ischemic heart disease1 intervention

Trial outcomes

Primary outcomes

1

Absolute coronary flow

Measurement of absolute coronary flow with/without CRT-function

Time frame
During procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ashkan Eftekhari

Lead sponsor

Aalborg University Hospital

Sponsor institution