Cardiac Resynchronization, Conduction System Pacing, Heart Failure, Left Bundle-Branch Block
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of conduction system pacing versus biventricular pacing in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.
Interventions
DEVICEConduction system pacing
Pacing from the His-Purkinje system (His-bundle pacing, left bundle branch area pacing, or deep septal pacing).
DEVICEBiventricular pacing
Pacing from the coronary sinus and right ventricular leads.
Sponsors
Ministry of Health, Brazil
Hospital Moinhos de Vento
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age ≥18 years * Established diagnosis of symptomatic heart failure (New York Heart Association class II-III) * Left ventricular ejection fraction ≤35% in prior 3 months * Left bundle branch block (QRS ≥130 ms) * Clinical indication for cardiac resynchronization therapy * Patients should be clinically stable * Patients should receive background standard of care for heart failure with reduced ejection fraction, with the maximum tolerated doses of ACE inhibitor or ARB or ARNI, beta-blocker, and mineralocorticoid receptor antagonist
Exclusion criteria
* Life expectancy \<12 months due to any disease * Dementia or advanced cerebrovascular disease * NYHA class IV * Plan to implant an implantable cardioverter defibrillator (ICD), with or without resynchronization therapy (CRT-D) * Enrollment in other clinical trials involving cardiac pacing * Pregnancy or pre-menopausal women who do not use regular contraceptive methods * Patients unable to understand and sign the consent for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | 12 months | Heart failure-related net composite outcome, a hierarchical composite of all-cause death, any hospitalization for heart failure, any urgent heart failure visit, and left ventricular ejection fraction change at 12 months. The category of the composite outcome for each patient will be determined by assessing the following criteria sequentially, stopping when the event is present: All-cause death: death during follow-up. Hospitalization for heart failure: any hospitalization for heart failure during follow-up. Urgent heart failure visit: any urgent heart failure visit during follow-up. Left ventricular ejection fraction change: the difference between baseline and follow-up, categorized by every 5-point change. The distribution of outcome categories will be compared by ordinal distribution analysis. Non-inferiority margin: odds ratio \<1.2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular end-diastolic volume | 12 months | — |
| Change in natriuretic peptide values | 12 months | BNP and NT-proBNP |
| Change in 6-minute walk test | 12 months | — |
| Key secondary outcome: Cost analysis (dominance) (superiority) | 12 months | Mean total direct medical cost per patient at 12 months. |
| Change in left ventricular ejection fraction | 12 months | — |
| Change in NYHA Classification | 12 months | New York Heart Association Functional Class |
| Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score | 12 months | The Kansas City Cardiomyopathy Questionnaire Overall Summary Score ranges from 0-100, where a lower score indicates a worse outcome. |
| EuroQol Group 5-Dimensions questionnaire (EQ-5D) | 12 months | — |
| Hierarchical endpoint of death, hospitalization for heart failure, urgent heart failure visit, and change in KCCQ Clinical Summary Score | 12 months | — |
| Change in QRS complex | Duration of the QRS complex, defined as the widest paced QRS complex rated at 12-lead ECG, measured immediately after the index procedure | — |
Other
| Measure | Time frame |
|---|---|
| Change in peak oxygen consumption (VO2) | 12 months |
Countries
Brazil
Outcome results
None listed