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

NCT05564689 | Recruiting

• 1 other identifier: N-20220040
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

absolute coronary flow; fractional flow reserve

Outcome Measures

Primary Outcomes (1)

• Absolute coronary flow

  Measurement of absolute coronary flow with/without CRT-function

  During procedure

Study Arms (1)

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

Procedure: Intracoronary flow and pressure

Interventions

Intracoronary flow and pressure PROCEDURE

Measurement of absolute coronary flow and resistance

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18
• QRS ≥ 150 ms before implantation
• Heart failure because of dilated cardiomypathy
• Sinus rhythm
• Stable medical therapy
• LBBB
• CRT device

You may not qualify if:

• 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

Sponsors & Collaborators

• Ashkan Eftekhari: lead

Study Sites (1)

Aalborg Universityhospital

Aalborg, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Bundle-Branch Block; Heart Failure; Cardiomyopathy, Dilated

Interventions

Pressure

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Ashkan Eftekhari

  Department of Cardiology, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashkan Eftekhari

CONTACT

004528973764; asef@rn.dk

Sanna Gunnarstein

CONTACT

004542918950; s.gunnarstein@rn.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: September 29, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

DK (1)