Factors Associated With Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Non-LBBB ECG Pattern

NCT06977217 | Active Not Recruiting DMC

• 1 other identifier: STUDY00006153
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac resynchronization therapy with a defibrillator (CRT-D) in heart failure (HF) patients without left bundle branch block (non-LBBB) has been less beneficial to improve outcomes despite being a guideline indicated therapy, posing a significant treatment challenge. However, non-LBBB patients with echocardiography response to CRT-D have better outcomes, and pre-implant variables could predict response, identifying patients who benefit the most. In this study, we plan to enroll 270 HF patients with non-LBBB and guideline-indicated CRT-D implantation to validate our prior echocardiography predictor score, and to identify novel ECG and echocardiography predictors using conventional statistics and machine learning analysis. We will also assess the applicability of such a score for clinical outcomes of HF, ventricular arrhythmias, or death.

Conditions

Cardiomyopathies; Heart Failure; Non-left Bundle Branch Block; Cardiac Resynchronization Therapy

Keywords

Cardiomyopathies; Heart Failure; Non-left bundle branch block; Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

• LVESV improvement

  The primary endpoint of the study is a 25% or greater reduction in LV end-systolic volume 12 months after CRT-D implantation in HF patients with non-LBBB, analyzed by the central echocardiography core laboratory. Echocardiography outcomes will be assessed by sonographers blinded to patient characteristics or clinical outcomes to avoid bias.

  12 months

Secondary Outcomes (1)

• HF or death or VT or VF

  2 years

Interventions

CRT-D implantation PROCEDURE

Cardiac resynchronization therapy with a defibrillator (CRT-D). This combination device uses a pacemaker and an implantable cardioverter-defibrillator (ICD). It may be recommended for people with heart failure who also have a risk of sudden cardiac death. It can find dangerous heart rhythms and correct them. It can pace the heartbeat or shock the heart out of a dangerous heart rhythm.

Eligibility Criteria

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

Study Population

Study population will include 270 HF patients with non-LBBB and an implanted CRT-D device.

You may qualify if:

• Age 18 years or older (no upper limit)
• Optimal medical therapy for heart failure as established by current guidelines;
• Class IIa or IIb guideline-based indication for CRT-D in non-LBBB patients, including one of the following:
• New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb);
• NYHA class III-IVa HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa);
• NYHA class III-IVa HF, LVEF ≤ 35%, and QRS duration 120- 149 ms (IIb)
• Successful CRT-D generator implant

You may not qualify if:

• Unable to obtain imaging data from echocardiogram within 1 year prior to CRT-D implant
• Unable to obtain the 20-minute ECG prior to CRT-D implant
• Unable to enroll within 14 days following successful CRT-D generator implant
• Unable or unwilling to follow the study protocol
• Less than 24 months life expectancy at enrollment
• Pregnancy or planned pregnancy in the next 24 months

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Valentina Kutyifa, MD, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Cardiology), Tenured

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 18, 2025
• Study Start: March 21, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

US (1)