Personalized pacemaker rate setting to improve symptoms in heart failure with bradycardia

Clinical and Hemodynamic Outcomes of OPTimized PACing StratEgies in Heart Failure Patients With Pacing Indications: Randomized-Controlled Trial (OPTPACE-HF)

Researchers will try adjusting the pacemaker lower rate to a personalized, hemodynamically optimized heart rate to see if it reduces symptoms in people with heart failure who need a pacemaker.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Samsung Medical Center (Academic / other)
• Locations: 1 site (Seoul, Seoul)
• Trial ID: NCT07563153 on ClinicalTrials.gov

What this trial studies

This randomized trial compares an individualized, hemodynamically optimized pacemaker lower rate to a conventional lower rate of 60 bpm in patients with heart failure and symptomatic bradycardia. Patients are randomized 1:1; the optimized group undergoes post-procedural right heart catheterization to identify the heart rate that produces the lowest mean pulmonary capillary wedge pressure or the highest cardiac output, which is then programmed as the lower rate limit. The conventional group has the lower rate set to 60 bpm. Clinical status, including Kansas City Cardiomyopathy Questionnaire score, and hemodynamic parameters are compared over a 12-month follow-up.

Who should consider this trial

Good fit: Adults with symptomatic bradycardia who need a permanent pacemaker and have heart failure with LVEF ≥ 50% (HFpEF) meeting objective criteria such as high H2FPEF/HFA‑PEFF scores, elevated natriuretic peptides, prior HF hospitalization, or loop diuretic use are ideal candidates.

Not a fit: Patients expected to have a high ventricular pacing burden (≥20%) without physiological pacing capture, those with reduced LVEF (<50%), or those unable to undergo right heart catheterization are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, personalized lower-rate pacemaker settings could reduce heart failure symptoms and improve quality of life over one year.

How similar studies have performed: Small hemodynamic and pilot studies have suggested benefits from moderately higher pacing rates or conduction system pacing, but large randomized evidence is limited.

Eligibility criteria

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.

Where this trial is running

Seoul, Seoul

• Samsung Medical Center — Seoul, Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Juwon Kim, MD

Conditions Heart Failure; Bradycardia; Heart failure; bradycardia; CIED; lower rate