Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication (ESCPAND)

This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction; Heart Conduction Disorder
• Intervention / Treatment: Device: Conduction system pacing; Device: Right ventricular apical pacing

Detailed Description

Heart failure (HF) is a serious condition that affects a lot of people and places a significant burden on the healthcare system. Some HF patients also have issues with the natural electrical system of their heart, causing uneven heart contractions and worsening heart function. A treatment known as CRT has been helping such patients, but it does not work for everyone. A new technique called conduction system pacing (CSP) has emerged that might offer a more natural way of maintaining heart contractions.

This study aims to determine if CSP can enhance the ability of HF patients to exercise, by looking at their maximum oxygen consumption (a measure of exercise capacity). It will also explore why some HF patients struggle with exercise more than others. Eligible patients will be randomly assigned to either the new CSP treatment or a standard pacing method (right ventricular apical pacing). Patients will be checked regularly over a follow-up period of 24 weeks.

The main goal is to see if patients can exercise better with CSP after 24 weeks. The study will also look at other heart measures and safety concerns related to the devices. This study might show that CSP can help improve exercise capacity and heart function in certain HF patients. The results could guide health care professionals in offering better, tailored treatments for their patients.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Gevaert; Phone Number: 038213538; Email: Andreas.gevaert@uza.be
• Study Contact Backup: Name: Faro Verelst; Phone Number: 038213538; Email: faro.verelst@uza.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Universitair Ziekenhuis Antwerpen
      • Contact: Faro Verelst; Phone Number: 038213538; Email: faro.verelst@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients with heart failure as defined by European Society of Cardiology guidelines

• Signs and/or symptoms of heart failure
• AND LVEF <50% OR LVEF ≥50% and objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised filling pressures
• AND indication for cardiac pacing as defined by European Society of Cardiology guidelines

Exclusion Criteria:

• Age under 18 years old
• Pregnancy
• Inability to provide consent or to undergo follow-up
• Class 1A indication for classical CRT as defined by European Society of Cardiology guidelines. Patients with a class 2A or higher indication for CRT can be included. However, patients with Class 1A indication for classical CRT but failure or suboptimal result of CS lead placement can be included.
• Significant cardiac or extracardiac comorbidity precluding maximal exercise testing, examples: Recent (<4 weeks) decompensation of heart failure, angina pectoris class ≥2 , uncontrolled hypertension or arrhythmia , severe valvular heart disease, significant peripheral vascular disease, orthopaedic limitation ...
• Comorbidity that may influence 6-month prognosis, examples:

Severe chronic kidney disease (eGFR ≤20 mL/kg/min or dialysis) , severe chronic obstructive pulmonary disease (≥GOLD 3) , active malignancy ...

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conduction system pacing; In the conduction system pacing group, the right ventricular lead will be placed in a septal position to achieve conduction system pacing, either His bundle pacing (HBP) or left bundle branch area (LBBA) pacing.	Device: Conduction system pacing; In the conduction system pacing group, the right ventricular lead will be placed in a septal position to achieve conduction system pacing, either His bundle pacing (HBP) or left bundle branch area (LBBA) pacing. In the usual care group, the right ventricular lead will be placed in the right ventricle apex as usual.
Active Comparator: Right ventricular apical pacing; Control group, in this group patients will receive a pacemaker with the ventricular lead in the right ventricle apex.	Device: Right ventricular apical pacing; This is the usual care group. Patients will receive a pacemaker device with the right ventricular lead inserted in the apex and not in the septal position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Change of VO2 peak from baseline to 24 weeks	24 weeks after pacemaker implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Change of VO2 peak from baseline to 4 weeks	4 weeks after pacemaker implantation
Echocardiographic parameters (Ejection Fraction)	Change from baseline to 4,12 and 24 weeks (EF%)	4, 12 and 24 weeks after pacemaker implantation
QRS width	Change from baseline to 4,12,24 weeks (msec)	4, 12 and 24 weeks after pacemaker implantation
Biomarker, N-terminal pro B-type natriuretic peptide levels	Change from baseline to 4, 24 weeks (pg/ml)	4 and 24 weeks after pacemaker implantation
Health-related quality of life scores	KCCQS - Kansas City cardiomyopathy quality score	4,12 and 24 weeks after pacemaker implantation

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Andreas Gevaert, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: exercise capacity; Cardiopulmonary exercise testing; conduction system pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Cardiac Conduction System Disease
• Other Study ID Numbers: 3020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes