Bradycardia, Heart Failure
Conditions
Keywords
Heart failure, bradycardia, CIED, lower rate
Brief summary
This study aims to evaluate the clinical impact of an optimized pacing strategy in patients with heart failure. * Intervention: Adjustment of the pacemaker lower rate limit to an individualized, hemodynamically optimized heart rate. * Primary Endpoint: Heart failure symptoms, assessed by the Kansas City Cardiomyopathy Questionnaire score. * Hypothesis: In patients with heart failure requiring permanent pacing, an optimized pacing strategy will lead to a significant improvement in heart failure symptoms (Kansas City Cardiomyopathy Questionnaire score) at 12 months compared with the conventional pacing strategy.
Detailed description
Heart failure is a growing health concern with increasing prevalence in the aging population, and permanent pacemaker implantation is frequently required due to concomitant bradyarrhythmias. Heart rate is closely associated with hemodynamic status in patients with heart failure; however, evidence guiding the optimal pacemaker lower rate setting remains limited. Although the conventional lower rate is typically set at 50-60 bpm, recent studies suggest that a moderately increased pacing rate may improve hemodynamics and clinical outcomes. Furthermore, advances in physiological pacing techniques, such as conduction system pacing, provide the potential for greater clinical benefits through optimized heart rate settings in this patient population. Enrolled subjects are randomized in a 1:1 ratio into either the optimized pacing group or the conventional pacing strategy group based on stratification factors. The optimized pacing group undergoes post-procedural right heart catheterization with adjustments to the lower rate limit, where the heart rate (HR) that yields the lowest mean pulmonary capillary wedge pressure (mPCWP) or the highest cardiac output is determined as the optimal HR. In the conventional pacing strategy group, the lower rate limit is set at 60 bpm. Clinical symptoms and parameters of both groups are subsequently compared over a one-year follow-up period.
Interventions
PROCEDUREAdjustment of the pacemaker/ICDs lower rate limit (LRL)
Optimized Pacing Strategy
PROCEDUREConventional lower rate (60bpm)
Conventional Pacing Strategy
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions: 1. Sick sinus syndrome with or without impaired atrioventricular conduction 2. Persistent or permanent atrial fibrillation with slow ventricular response 3. Chronotropic incompetence * Patients diagnosed with heart failure with left ventricular ejection fraction ≥ 50% on transthoracic echocardiography with at least one of the following: * H2FPEF score ≥ 6 or HFA-PEFF score ≥ 5 * N-terminal pro-B-type natriuretic peptide ≥ 300 pg/mL (sinus rhythm) or ≥ 600 pg/mL (atrial fibrillation) * Prior hospitalization for heart failure or documented use of loop diuretics for heart failure symptoms
Exclusion criteria
* Patients expected to have a ventricular pacing burden ≥ 20% without sufficient capture of cardiac physiologic pacing, which includes biventricular pacing, His bundle pacing, and left bundle branch area pacing. (Sufficient cardiac physiologic pacing is defined as a paced QRS duration ≤ 140 ms.) * Patients not expected to achieve sufficient pacing dependency, defined as: 1. In sinus rhythm: baseline atrial rate \> 60 bpm on Holter monitoring or inpatient ECG monitoring 2. In atrial fibrillation/flutter: baseline ventricular rate \> 60 bpm on Holter monitoring or inpatient ECG monitoring * Patients with contraindications to permanent pacemaker implantation * Patients with moderate or greater valvular stenosis or regurgitation. * Patients with dyspnea not attributable to heart failure, due to uncontrolled comorbid conditions * Pregnant or breastfeeding women. * Patients who have refused active treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire | From enrollment to 1year after the procedure | Higher scores indicate better health status and a higher quality of life, score 0 to 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NTproBNP | From enrollment to 1year after the procedure | pg/mL (picograms per milliliter) |
| Functional status (NYHA class) | From enrollment to 1year after the procedure | class I to IV, higher NYHA classes indicate poorer functional status. |
| Distance in 6-minute walk test | From enrollment to 1year after the procedure | m |
| Occurrence of atrial fibrillation | From enrollment to 1year after the procedure | Documented incidence of atrial fibrillation on 12-lead ECG |
| Atrial fibrillation burden | From enrollment to 1year after the procedure | Atrial fibrillation burden(%) recorded by CIEDs |
| Invasive hemodynamics parameters in right heart catheterization | At the time of CIED implantation | pressure of RA, RV, PA, PCWP as mmHg Cardiac output as L/min (Liters per minute) |
| CIED Battery longevity | From enrollment to 1year after the procedure | year |
| All-cause mortality | From enrollment to 1year after the procedure | All-cause mortality rate(%) during 1year follow-up |
| Cardiac mortality | From enrollment to 1year after the procedure | Cardiac mortality rate(%) during 1year follow-up |
| Re-hospitalization due to all cause | From enrollment to 1year after the procedure | All cause re-hospitalization rate(%) during 1year follow-up |
| Hospitalization due to heart failure | From enrollment to 1year after the procedure | Hospitalization due to heart failure rate(%) during 1year follow-up |
| Average heart rate | From enrollment to 1year after the procedure | Average heart rate(bpm) monitored by the device |
| Heart rate distribution | From enrollment to 1year after the procedure | heart rate distribution recorded in CIED (% of total time) 60bpm to 70 70bpm to 80 80bpm to 90 90bpm to 100 over 100bpm |
| Pacing burden | From enrollment to 1year after the procedure | Atrial pacing and ventricular pacing burden(%) recorded in CIEDs |
| Peak oxygen consumption(Peak VO2) and Oxygen consumption at anaerobic threshold(VO2 at AT) | From enrollment to 1year after the procedure | Peak VO2 and VO2 at AT measured by cardiopulmonary exercise test. Both parameter calculated in mL/kg/min |
| LV ejection fraction (LVEF) | From enrollment to 1year after the procedure | LVEF(%) measured by echocardiogram |
| E/e' ratio measured by echocardiogram | From enrollment to 1year after the procedure | E/e' ratio, calculated as the ratio of early mitral inflow velocity (E) to early diastolic mitral annular velocity (e'), both velocities measured in m/s. |
| Cardiac index | From enrollment to 1year after the procedure | Cardiac index(as L/min/m\^2) measured with echocardiogram and body surface area |
| Peak TR velocity | From enrollment to 1year after the procedure | Peak TR velocity(TR V max) measured by echocardiogram (m/s) |
| Left atrial strain | From enrollment to 1year after the procedure | Left atrial strain(%) measured by echocardiogram |
| ECG parameters | From enrollment to 1year after the procedure | QRS duration, QT interval, P wave duration, PR interval (as ms) |
Countries
South Korea
Contacts
CONTACTJuwon Kim, MD
Outcome results
None listed