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Exploratory Study of Guideline-Directed Medical Therapy (GDMT) Withdrawal in HFrEF Patients with LBBB Achieving Complete Ventricular Reverse Remodeling Following Conduction System Pacing

Exploratory Study of Guideline-Directed Medical Therapy (GDMT) Withdrawal in HFrEF Patients with LBBB Achieving Complete Ventricular Reverse Remodeling Following Conduction System Pacing

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119368
Enrollment
Unknown
Registered
2026-02-26
Start date
2026-03-02
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure with Reduced Ejection Fraction (HFrEF)

Interventions

Withdrawing Guideline-Directed Medical Therapy Group:None
Regular GDMT Use Group:None

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years. 2.HFrEF patients who received CSP treatment according to CSP implantation guidelines due to sinus rhythm, LBBB, and LVEF 50% by Simpson’s method, LVESD or LVEDD within normal range;NT-proBNP or BNP within normal range) with no heart failure events 5.Regular adherence to GDMT for at least 3 months prior to GDMT withdrawal. 6.Complete medical records stored in the electronic medical record (EMR) database of the corresponding center, collected in a de-identified manner.

Exclusion criteria

Exclusion criteria: 1.Presence of other structural heart diseases (e.g.valvular heart disease requiring or previously treated with surgical intervention, secondary cardiomyopathy, etc.) 2.History of cardiac surgery or intracardiac implants (e.g., mechanical tricuspid valve replacement). 3.Persistent or permanent atrial fibrillation or atrial flutter. 4.Pregnancy or planning to become pregnant. 5.Severe hepatic or renal insufficiency. 6.Documented ventricular tachyarrhythmia events (VT/VF) during post-operative follow-up or device programming. 7.Life expectancy of less than 1 year. 8.Loss to follow-up. 9.Severely incomplete or missing key data..

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fraction, LVEF;B-type natriuretic peptide, BNP;N-terminal pro-B-type natriuretic peptide, NT-proBNP;Electrocardiogram, ECG;New York Heart function classification, NYHA;Medication status;—

Secondary

MeasureTime frame
Pacemaker threshold, sensing, impedance, pacing ratio;Blood lipids (TC, TG, LPa, LDL, HDL);(High-sensitivity) troponin I, (hs-)cTnI;Biochemical liver and kidney function tests;Routine blood test;Electrolytes;—

Countries

China

Contacts

Public ContactYunlong Xia

The First Affiliated Hospital of Dalian Medical University

yunlong_xia@126.com+86 180 9887 5555

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026