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Heart FailureEarly-RESYNCNCT06126081

Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy

A study testing LBBP+GDMT and GDMT in people with Heart Failure and Left Bundle Branch Pacing, run by Fu Wai Hospital, Beijing, China at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a two-center, prospective randomized controlled trial. The aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and guideline-directed medical therapy in heart failure with mild-reduced ejection fraction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Left Bundle Branch Pacing
What is being tested?
LBBP+GDMT and GDMT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesChina
Study dates
26 Jun 2023to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years;
  • symptomatic heart failure despite guideline-directed medical therapy for at least 3 months, NYHA class II-IV, with an EF between 35% and 50%;
  • complete LBBB meeting Strauss's standard definition
  • Signed informed consent.

Who cannot join

  • Expected survival less than 24 months;
  • Indicated for ICD or pacing therapy;
  • History of VT, VF, or hemodynamic instability;
  • History of mechanical tricuspid valve replacement;
  • Ischemic cardiomyopathy scheduled for CABG and PCI within 3 months;
  • Severe structural heart disease may necessitate cardiac surgery or heart transplantation within 1 year;
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  • Pregnancy or planning for pregnancy;
  • Hypertrophic cardiomyopathy or those underwent ventricular septal defect repair, in whom the success of LBBP is anticipated to be challenging;
  • Severe renal dysfunction (eGFR < 15ml/min*1.73m^2).

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037

  • The first affiliated hospital of Nanjing medical university

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy Compared With Guideline-directed Medical Therapy in Heart Failure With Mild-reduced Ejection Fraction.

This is a two-center, prospective randomized controlled trial. The aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and guideline-directed medical therapy in heart failure with mild-reduced ejection fraction.

Read the detailed description

Early-resync is a two-center, prospective randomized controlled trial that is designed to determine whether early left bundle branch pacing has a better impact on LV function improvement as compared with traditional guideline-directed medical therapy in heart failure with mild-reduced ejection fraction（36%≤LVEF≤50%） and complete left bundle branch block (CLBBB). Patients with symptomatic heart failure,36%≤LVEF≤50%, NYHA function class II-IV, and CLBBB（according to STRAUSS criteria) will be 1:1 randomized to LBBP+GDMT or GDMT group after enrollment and be followed at 3 and 6 months after randomization. LBBP will be performed by a double-chamber device in LBBP+GDMT group. All patients will receive GDMT. The primary endpoint is the change in the LVEF at 6 months after randomization from baseline.

Being tested
LBBP+GDMT, GDMT
Keywords
Heart Failure, Left Bundle Branch Pacing, Guideline-Directed Medical Therapy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LBBP+GDMTDevice

    Also called Early Resynchc

    LBBP is a procedure that the pacing lead is placed at the left bundle branch to achieve electrical and mechanical synchronization by pacing the left bundle branch area with stable pacing parameters.

  • GDMTDrug

    Also called Conventional treatment

    GDMT is defined as the drug strategy for treatment of heart failure according to the current guidelines.

Study groups in NCT06126081
Study groupRoleWhat they receive
LBBP+GDMT groupExperimentalPatients in the LBBP+GDMT group will receive LBBP using dual-chamber device as priority and guideline-directed medical therapy. The pacing lead will be implanted at the left bundle branch and whether LBB is captured will be judged during the procedure. For patients who LBBP is failed, CRTP using triple-chamber device or LVSP by using dual-chamber device will be an alternative option according to the co-determination after consultation between doctors and patients .
Receives: Device: LBBP+GDMT
GDMT groupActive comparatorPatients in the GDMT group will receive guideline-directed medical therapy according to their complications, heart rate, blood pressure and so on. During follow-up of 6 months, patients may transfer to LBBP group if the LVEF decreased to <35% and patients accepted the device implantation.
Receives: Drug: GDMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ΔLVEF between baseline and 6-month follow-up

    ΔLVEF：change in LVEF in percentage (%) between baseline and 6-month follow-up

    Measured: 6 months

Secondary outcomes (8)

  1. ΔLVEDD and ΔLVESV between baseline and 6-month follow-up

    ΔLVEDD：change in LVEDD in millimeters between baseline and 6-month follow-up between two groups.

    ΔLVESV：change in LVESV in milliliters between baseline and 6-month follow-up between two groups.

    Measured: 6 months

  2. The echocardiographic response rate of LVEF ≥50%

    the percentage of patients with LVEF ≥50% at 6 month follow-up

    Measured: 6 months

  3. The changes of NYHA function class between baseline and 6-month follow-up.

    NYHA function class (from I to IV) is evaluated by clinicians at each outpatient follow-up visit;

    Measured: 6 months

  4. Composite incidence rate of all-cause mortality and/or hospitalization for heart failure

    All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.

    Measured: 6 months

  5. The rate of LVEF <=35% at six-month

    The percentage of patients with LVEF <=35% at 6 month follow-up

    Measured: 6 months

  6. The changes of NT-proBNP between baseline and 6-month follow-up.

    NT-proBNP in pg/ml was measured by performing a blood test;

    Measured: 6 months

  7. The changes of 6MWD between baseline and 6-month follow-up.

    6MWD in meters stands for "6-Minute Walk Distance." It is a common test used to assess a person's functional exercise capacity and cardiovascular endurance. During the test, the patient is asked to walk as far as possible within a span of 6 minutes in a straight path or designated walking course;

    Measured: 6 months

  8. The changes of QoL between baseline and 6-month follow-up.

    QoL stands for "Quality of Life", which is measured by The Minnesota Living with Heart Failure Questionnaire (MLHFQ). The MLHFQ is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start26 Jun 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomized to two groups
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06126081
Sponsor's protocol ID
2023-1996
Acronym
Early-RESYNC
Status last verified
Dec 2025
First submitted
5 Sep 2023
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing LBBP+GDMT and GDMT in people with Heart Failure and Left Bundle Branch Pacing, run by Fu Wai Hospital, Beijing, China at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ΔLVEF between baseline and 6-month follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06126081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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