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RecruitingNCT05564689FLOW-LBBBUpdated Jun 18, 2025

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

An observational study in Left Bundle-Branch Block, Heart Failure and Cardiac Resynchronization Therapy, sponsored by Ashkan Eftekhari. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Ashkan Eftekhari · Observational

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Left Bundle-Branch Block
  • Heart Failure
  • Cardiac Resynchronization Therapy
  • Dilated Cardiomyopathy

Keywords

  • absolute coronary flow
  • fractional flow reserve
03

In context

Bundle-Branch Block

94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.

This study's planned enrollment of 60 is below the median of 162 across 33 observational studies indexed under Bundle-Branch Block.

Browse Bundle-Branch Block studies →

Lead sponsor

This is the only study on the registry with Ashkan Eftekhari as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • \< 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
  • Does not understand Danish
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with or in need of CRT, left bundle branch block, without ischemic heart disease

    Procedure: Intracoronary flow and pressure

Interventions

  • ProcedureIntracoronary flow and pressure

    Measurement of absolute coronary flow and resistance

06

What researchers measure

Primary outcomes

  1. Absolute coronary flow

    Measurement of absolute coronary flow with/without CRT-function

    Time frame: During procedure

07

Study locations

1 of 1 sites recruiting
  • Aalborg Universityhospital
    Aalborg, 9000, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05564689
Lead sponsor
Ashkan Eftekhari
Responsible party
Ashkan Eftekhari (Principal Investigator, Aalborg University Hospital) — Sponsor-investigator
First posted
Oct 3, 2022
Start date
Sep 29, 2022
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jun 18, 2025

Study contacts

Ashkan Eftekhari
Contact
asef@rn.dk
004528973764
Sanna Gunnarstein
Contact
s.gunnarstein@rn.dk
004542918950
Ashkan Eftekhari
principal investigator · Department of Cardiology, Aalborg University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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