Clinical trial NCT06969924: Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease
Official title: Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Congenital Heart Disease
Keywords: Adult congenital heart disease
Cardiac resynchronization therapy
ACHD
CRT
Heart failure
HF
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult congenital heart disease patients who received cardiac resynchronization therapy.

Brief summary: This study aims to evaluate the real-world effects of cardiac resynchronization therapy (CRT) in adult patients with congenital heart disease (ACHD). Specifically, it seeks to determine whether CRT improves clinical outcomes in this unique patient population and to identify factors associated with a favorable response to therapy.

Detailed description: Cardiac resynchronization therapy (CRT) is well-established in acquired heart failure, but evidence in ACHD remains limited. Current guidelines, extrapolated from non-congenital populations, may not fully address the anatomical and electrophysiological complexities in ACHD.

This retrospective cohort study aims to investigate the real-world efficacy and safety of CRT in adult patients with congenital heart disease (ACHD). The study includes consecutive ACHD patients who underwent either de novo CRT implantation or upgrade procedures, starting from January 2014.

The primary objectives are to evaluate changes in QRS duration, systemic ventricular function, and New York Heart Association (NYHA) functional class. The study aims to further examine the impact of CRT in specific ACHD subgroups, including patients with systemic right ventricles (vs. systemic left ventricles), those with non-left bundle branch block (non-LBBB) morphology (vs. LBBB), and those with upgrade procedures (vs. de novo implants).

Data collection is based on retrospective review of electronic health records, including patient demographics, clinical characteristics, device-related procedural details, and follow-up data. Outcomes are assessed using standardized echocardiographic and electrocardiographic measurements, alongside clinical evaluations.

The study aims to provide comprehensive real-world insights into the efficacy and safety of CRT in the diverse ACHD population and to identify predictors of favorable response, ultimately supporting more individualized decision-making in this complex patient group.

Eligibility criteria: Inclusion Criteria:

* ACHD patients who underwent CRT implantation

Exclusion Criteria:

* Less than 18 years old on the moment of CRT implantation
* Patient objection to the use of retrospective data

Primary outcomes:
measure: QRS duration
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Systemic ventricle function class
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: NYHA functional class
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
Secondary outcomes:
measure: Clinical - Mortality
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical - Heart failure hospitalization
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical - CV hospitalization other than HF
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical - Urgent heart failure visit
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical - Urgent CV visit other than HF
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical - Enlisting for LVAD
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical - Enlisting for HTX
timeFrame: One year after implantation
measure: Clinical - Periprocedurel complications
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: CIED-related - Threshold systemic ventricular lead
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: CIED-related - Impedance systemic ventricular lead
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: CIED-related - R-wave sensing systemic ventricular lead
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: CIED-related - ICD therapy
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Medication - GDMT use
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical parameter - weight
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical parameter - systolic blood pressure
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical parameter - diastolic blood pressure
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Clinical parameter - heart rate
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Laboratory parameter - sodium
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Laboratory parameter - creatinine
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Laboratory parameter - eGFR
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Laboratory parameter - NT-proBNP
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Laboratory parameter - hs-TnT
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Echocardiographic parameter - subpulmonary ventricle function class
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Echocardiographic parameter - SAVV regurgitant grade
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Echocardiographic parameter - PAVV regurgitant grade
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Echocardiographic parameter - sPAP
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
measure: Echocardiographic parameter - IVC diameter
timeFrame: From enrollment through study completion, with an average follow-up duration of 1 year.
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
state: Zuid-Holland
Study officials:
References: