Chronic Heart FailureNCT07877831
Vericiguat Use and Incident Atrial Fibrillation in Chronic Heart Failure
An observational study of Chronic Heart Failure, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This ambispective observational cohort study aims to evaluate the association between vericiguat treatment and incident atrial fibrillation in patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Vericiguat
- How many people
- 918 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Observational
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
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
No. 168 Litang Road, Changping District, Beijing, China
Beijing, Beijing Municipality, 102218
About this study
Official title: Association Between Vericiguat Treatment and Incident Atrial Fibrillation in Patients With Chronic Heart Failure: An Ambispective Cohort Study
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.
- Conditions
- Chronic Heart Failure
- Being tested
- Vericiguat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat Group | Patients with chronic heart failure who receive vericiguat as part of routine clinical care. Receives: Drug: Vericiguat | |
| Non-Vericiguat Group | Patients with chronic heart failure who do not receive vericiguat during routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Enrollment to 12 Months
Secondary outcomes (2)
All-Cause Death
Death from any cause during the follow-up period.
Measured: From Enrollment to 12 Months
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.
Measured: From Enrollment to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 918 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877831
- Sponsor's protocol ID
- 12026Z01023
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No