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Active, not recruitingNCT07877831Updated Oct 16, 2026

Vericiguat Use and Incident Atrial Fibrillation in Chronic Heart Failure

An observational study in Chronic Heart Failure, sponsored by Beijing Tsinghua Chang Gung Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Observational

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
918
Ages
18 Years and older
Sex
All
01

Study summary

This ambispective observational cohort study aims to evaluate the association between vericiguat treatment and incident atrial fibrillation in patients with chronic heart failure. Adult patients treated at Beijing Tsinghua Changgung Hospital between November 2023 and December 2026 will be included, with data collected retrospectively before January 2025 and prospectively thereafter.

Patients will be classified according to vericiguat use during routine clinical care. The non-vericiguat group will include patients receiving contemporary guideline-directed medical therapy for chronic heart failure without vericiguat. Treatment decisions will be made by treating physicians rather than assigned by the study investigators.

The primary outcome is incident atrial fibrillation during follow-up, including atrial fibrillation, atrial flutter, and subclinical atrial fibrillation. Secondary outcomes include all-cause death and major adverse cardiovascular events.

Read the detailed description

This is an ambispective observational cohort study designed to investigate whether vericiguat treatment is associated with a lower risk of incident atrial fibrillation in patients with chronic heart failure. The study will include eligible adult patients with chronic heart failure treated at Beijing Tsinghua Changgung Hospital from November 2023 to December 2026. Baseline and follow-up information will be collected retrospectively for patients treated before January 2025 and prospectively for patients treated thereafter.

Eligible patients will be grouped according to vericiguat exposure during routine clinical care. Patients in the vericiguat group will receive vericiguat in addition to standard heart failure therapy when clinically indicated. Patients in the non-vericiguat group will receive contemporary guideline-directed medical therapy for chronic heart failure without vericiguat. The study will not interfere with treatment decisions, and the use of vericiguat and other heart failure therapies will be determined by treating physicians based on patients' clinical conditions, indications, contraindications, drug availability, and tolerability.

The primary outcome is incident atrial fibrillation during follow-up. This includes newly diagnosed atrial fibrillation, atrial flutter, and subclinical atrial fibrillation identified by electrocardiography, Holter monitoring, or available data from implantable or wearable cardiac devices. Secondary outcomes include all-cause death and major adverse cardiovascular events during follow-up.

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Conditions studied

  • Chronic Heart Failure
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In context

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 102 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with chronic heart failure who are treated at Beijing Tsinghua Changgung Hospital between November 2023 and December 2026 and meet the study eligibility criteria will be included. Patients will be classified according to vericiguat use in routine clinical care and followed for 1 year to assess new-onset atrial fibrillation and cardiovascular outcomes.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older.
  • Diagnosis of chronic heart failure according to the 2024 Chinese guideline for the diagnosis and treatment of heart failure.
  • Heart failure with mildly reduced ejection fraction, reduced ejection fraction, or improved ejection fraction.
  • History, symptoms, or signs of heart failure.
  • NT-proBNP ≥125 ng/L or BNP ≥35 ng/L.
  • Left ventricular ejection fraction \<50% on echocardiography.
  • New York Heart Association functional class II to III.

Exclusion criteria

Exclusion Criteria:

  • Previous history of atrial fibrillation, or atrial fibrillation diagnosed by electrocardiography or Holter monitoring.
  • Acute heart failure or acute worsening of chronic heart failure.
  • Acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention within 1 month.
  • Amyloidosis, granulomatous disease, hypertrophic cardiomyopathy, myocarditis, or stress cardiomyopathy.
  • Untreated moderate-to-severe mitral stenosis or mechanical prosthetic heart valve.
  • Major congenital heart disease, or simple congenital heart disease with residual hemodynamic lesions.
  • Uncontrolled hyperthyroidism.
  • Severe hepatic impairment, defined as Child-Pugh class C.
  • End-stage renal disease, defined as eGFR ≤15 mL/min/1.73 m2, or chronic dialysis.
  • Severe pulmonary disease requiring long-term oxygen therapy.
  • Pregnancy, breastfeeding, or planned pregnancy.
  • End-stage disease other than heart failure, such as malignant tumor or other disease with life expectancy \<1 year.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
918 participants (estimated)
Patient registry
No

Groups and cohorts

  • Vericiguat Group

    Patients with chronic heart failure who receive vericiguat as part of routine clinical care.

    Drug: Vericiguat

  • Non-Vericiguat Group

    Patients with chronic heart failure who do not receive vericiguat during routine clinical care.

Interventions

  • Patients in the vericiguat group receive vericiguat as part of routine clinical care for chronic heart failure. The study does not assign treatment; vericiguat use is determined by the treating physician according to clinical practice.

06

What researchers measure

Primary outcomes

  1. New-Onset Atrial Fibrillation

    Occurrence of new-onset atrial fibrillation, atrial flutter, or subclinical atrial fibrillation during follow-up. Atrial fibrillation and atrial flutter will be identified by 12-lead electrocardiography, Holter monitoring, or available data from implanted or wearable cardiac devices. Subclinical atrial fibrillation is defined as atrial fibrillation lasting more than 5 minutes detected by a cardiac implantable electronic device or wearable device.

    Time frame: From Enrollment to 12 Months

Secondary outcomes

  1. All-Cause Death

    Death from any cause during the follow-up period.

    Time frame: From Enrollment to 12 Months

  2. Major Adverse Cardiovascular Events

    Occurrence of a composite outcome including nonfatal stroke, transient ischemic attack, peripheral arterial embolism, nonfatal myocardial infarction, hospitalization for heart failure or other cardiovascular events, and cardiovascular death during follow-up.

    Time frame: From Enrollment to 12 Months

07

Study locations

1 site
  • No. 168 Litang Road, Changping District, Beijing, China
    Beijing, Beijing Municipality 102218, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07877831
Responsible party
Sponsor
First posted
Oct 16, 2026
Start date
Nov 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 16, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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