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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Patients with symptomatic bradycardia who meet the indication for permanent pacemaker implantation and fulfill one of the following conditions:

‣ Sick sinus syndrome with or without impaired atrioventricular conduction

⁃ Persistent or permanent atrial fibrillation with slow ventricular response

⁃ 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

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Juwon Kim, MD
abcd186a@naver.com
82-10-2079-8154
Time Frame
Start Date: 2025-12-18
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 106
Treatments
Experimental: Optimized pacing strategy
Optimized Pacing Strategy~* Definition of Optimal Heart Rate: After permanent pacemaker implantation, a hemodynamic evaluation will be performed using right heart catheterization with stepwise incremental pacing rates of 60, 70, 80, and 90 bpm. If the optimal heart rate is identified at one of these 10-bpm intervals, additional assessments will be conducted in 5-bpm increments around that rate to further refine the optimal pacing rate.~* Invasive hemodynamic parameters assessed include: Mean pulmonary capillary wedge pressure, Cardiac output (thermodilution)~* The optimal heart rate is defined as the pacing rate associated with the lowest mean pulmonary capillary wedge pressure or highest cardiac output.~* To ensure hemodynamic stabilization, a 5-minute washout period will be applied between rate changes.~* To minimize the confounding effects of intrinsic bradycardia below 60 bpm, optimized pacing will be performed after a stabilization period of 2 weeks following permanent pacemaker.
Active_comparator: Conventional pacing strategy
Conventional Pacing Strategy~• The conventional pacing group will have the pacemaker's lower rate limit set at a fixed 60 bpm, in accordance with current standard practice.
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov