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RecruitingNCT07047547ESVGR-HFUpdated Jul 9, 2025

A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure

An interventional study of Vericiguat in Hemodialysis Complication and Heart Failure, sponsored by Guangdong Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Chronic Kidney Disease often requires dialysis and other treatments to sustain life, and patients frequently suffer from heart failure, which exacerbates the disease burden. Research has shown that the incidence of heart failure is high among patients on dialysis, and the prognosis is poor. In recent years, there has been significant progress in the treatment of heart failure. Vericiguat, a novel sGC stimulator, can improve cardiac function and exercise tolerance, reduce the risk of cardiovascular death and hospitalization for heart failure, and has good tolerance. It has been included in relevant guidelines as a recommended drug. It has good tolerance in patients with renal insufficiency, and its therapeutic effect is consistent in patients with different levels of eGFR. However, there is a lack of prospective, randomized controlled studies targeting the special population of patients on dialysis. This study is a prospective, observational, single-arm study, planning to recruit 118 patients from June 2025 to June 2026. It aims to assess the efficacy and safety of Vericiguat in patients with heart failure on hemodialysis, to provide new evidence-based medical evidence for the treatment of heart failure in this special population, optimize the treatment strategy, and improve the prognosis and quality of life.

02

Conditions studied

  • Hemodialysis Complication
  • Heart Failure

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Keywords

  • Vericiguat
  • Heart failure
  • Hemodialysis Complication
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 118 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The patient is aged between 18 and 80 years
  • Suffering from chronic kidney disease (eGFR\<90ml/min/1.73m², by CKD-EPI formula).
  • They have chronic heart failure (NYHA class ≥II), with reduced ejection fraction, defined as LVEF≤50%.
  • Their serum potassium level has been ≤4.8 mmol/L in the past month.
  • For women of childbearing potential, the pregnancy test result is negative at the screening visit and they agree.
  • Adequate contraceptive measures are taken.
  • The patient's dialysis adequacy assessment has reached Kt/V >1.2, or URR>70%.
  • The study protocol is implemented after being approved by the hospital ethics committee, and all patients voluntarily participate in this study

Exclusion criteria

Exclusion Criteria:

  • Acute renal failure.
  • Systolic blood pressure below 90 mmHg at screening (systolic blood pressure less than 95 mmHg during interdialytic period).
  • Isolated right heart failure due to pulmonary disease; the primary cause of dyspnea is due to non-cardiac, non-heart failure reasons, such as acute or chronic respiratory diseases.
  • History of myocardial infarction or cerebrovascular event within the past 3 months.
  • History of angioedema.
  • Hemodialysis patients with dialysis frequency less than 3 times per week.
  • Significant laboratory abnormalities at screening that interfere with the assessment of the safety or efficacy of the study drug (e.g., serum potassium > 5.5 mmol/L or \< 3.5 mmol/L, serum sodium \< 130 mmol/L, or alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of the normal range).
  • History of kidney transplantation or planned kidney transplantation within the next 12 months.
  • Use of medications for pulmonary arterial hypertension, such as sildenafil, during the study period.
  • Known allergy to the study treatment (active substance or excipients).
  • Any other disease or treatment that makes the patient ineligible to participate in this study or to complete the entire planned study period (e.g., active malignancy or other diseases that limit life expectancy to less than 12 months).
  • Pregnant or breastfeeding during the study period, or intending to become pregnant.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
118 participants (estimated)

Study arms

  • Experimental
    Vericiguat

    Under the premise of ensuring safety, treat with a stable dose of Vericiguat 2.5mg PO QD for 2 weeks. After 2 weeks, increase the dose to 5mg PO QD. If blood pressure elevation occurs during the operation phase, the researchers suggest titrating or starting additional antihypertensive drugs, with a follow-up of 12 months. If the patient has tolerability issues (symptomatic hypotension or SBP\<90 mmHg), the dose should be reduced or discontinued.

    Drug: Vericiguat

Interventions

  • DrugVericiguat

    Under the premise of ensuring safety, treat with a stable dose of Vericiguat 2.5mg PO QD for 2 weeks. After 2 weeks, increase the dose to 5mg PO QD. If blood pressure elevation occurs during the operation phase, the researchers suggest titrating or starting additional antihypertensive drugs, with a follow-up of 12 months. If the patient has tolerability issues (symptomatic hypotension or SBP\<90 mmHg), the dose should be reduced or discontinued.

06

What researchers measure

Primary outcomes

  1. Left ventricular ejection fraction(LVEF)

    Change from baseline in left ventricular ejection fraction(LVEF)between baseline and end of study

    Time frame: 12weeks

  2. Left ventricular ejection fraction (LVEF)

    Change from baseline in left ventricular ejection fraction (LVEF) between baseline and end of study

    Time frame: 12weeks

Secondary outcomes

  1. N terminal proB type natriuretic peptide (NT-prpBNP)

    Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic pel proBNP) every 2 weeks

    Time frame: 12 weeks

  2. Left ventricular end diastolic volume (LVEDV)

    LVEDV is measured as baseline and after 12 weeks follow-up.

    Time frame: 12 weeks

  3. Left atrial volume (LAV)

    LAVis measured as baseline and after 12 weeks follow-up.

    Time frame: 12 weeks

  4. The ratio of mitral early diastolic blood flow peak and mitral annulus velocity (E/E')

    E/E' is measured as baseline and after 12 weeks follow-up.

    Time frame: 12 weeks

  5. Pulmonary Artery Pressure

    Pulmonary Artery Pressure is measured as baseline and after 12 weeks follow-up.

    Time frame: 12 weeks

  6. Concentration of high-sensitivity serum troponin T

    Blood samples will be collected for analysis of concentration of serum troponin every 4 weeks.

    Time frame: 12 weeks

  7. Minnesota Heart Failure Quality of Life Questionnaire (LiHFe)

    Change in health status is assessed using the disease-specific Minnesota Heart Failure Quality of L Questionnaire.

    Time frame: 12 weeks

  8. Systolic and diastolic blood pressure

    Systolic and diastolic blood pressure will be measured every 2 weeks.

    Time frame: 12 weeks

  9. Electrocardiogram(ECG)

    ECG QT Interval analysis was performed at baseline and 12 weeks follow-up.

    Time frame: 12 weeks

  10. Estimated glomerular filtration rate(eGFR)

    changes in estimated glomerular filtration rate(eGFR)

    Time frame: 12 weeks

Other outcomes

  1. Neprilysin

    The concentration of Neprilysis is measured by Human Neprilysin ELISA Kit as baseline and after 12 weeks following up

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 510000, China
    • ShuangXin Liu · Contact · gdphgcp@gdph.org.cn · (+86)020-83525210
    • ShuangXin Liu · Principal investigator
    • Sijia Li · Principal investigator
    • Jianchao Ma · Principal investigator
    • Zhonglin Feng · Principal investigator
    • Zhuo Li · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07047547
Lead sponsor
Guangdong Provincial People's Hospital
Responsible party
ShuangXin Liu (Chief Physician, Guangdong Provincial People's Hospital) — Principal investigator
First posted
Jul 2, 2025
Start date
Jun 1, 2025
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Jul 9, 2025

Study contacts

Shuangxin Liu
Contact
gdphgcp@gdph.org.an
(+86)020-83525210
Shuangxin Liu
principal investigator · Guangdong Provincial People's Hospital

Oversight

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

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