Hemodialysis ComplicationESVGR-HFNCT07047547
A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure
A study testing Vericiguat in people with Hemodialysis Complication and Heart Failure, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis Complication, Heart Failure
- What is being tested?
- Vericiguat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
ShuangXin Liu, (+86)020-83525210, gdphgcp@gdph.org.cn
ShuangXin Liu
About this study
Official title: A Prospective, Observational, Single-arm Study to Evaluate the Efficacy and Safety of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure.
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.
- Conditions
- Hemodialysis Complication, Heart Failure
- Being tested
- Vericiguat
- Keywords
- Vericiguat, Heart failure, Hemodialysis Complication
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat | Experimental | 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. Receives: Drug: Vericiguat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction(LVEF)
Change from baseline in left ventricular ejection fraction(LVEF)between baseline and end of study
Measured: 12weeks
Left ventricular ejection fraction (LVEF)
Change from baseline in left ventricular ejection fraction (LVEF) between baseline and end of study
Measured: 12weeks
Secondary outcomes (10)
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
Measured: 12 weeks
Left ventricular end diastolic volume (LVEDV)
LVEDV is measured as baseline and after 12 weeks follow-up.
Measured: 12 weeks
Left atrial volume (LAV)
LAVis measured as baseline and after 12 weeks follow-up.
Measured: 12 weeks
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.
Measured: 12 weeks
Pulmonary Artery Pressure
Pulmonary Artery Pressure is measured as baseline and after 12 weeks follow-up.
Measured: 12 weeks
Concentration of high-sensitivity serum troponin T
Blood samples will be collected for analysis of concentration of serum troponin every 4 weeks.
Measured: 12 weeks
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.
Measured: 12 weeks
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured every 2 weeks.
Measured: 12 weeks
Electrocardiogram(ECG)
ECG QT Interval analysis was performed at baseline and 12 weeks follow-up.
Measured: 12 weeks
Estimated glomerular filtration rate(eGFR)
changes in estimated glomerular filtration rate(eGFR)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShuangXin Liu, Guangdong Provincial People's Hospital
- Investigators
- Shuangxin Liu, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047547
- Sponsor's protocol ID
- 20250624
- Acronym
- ESVGR-HF
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Single-arm Study to Evaluate the Efficacy and Safety of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure.
- ClinicalTrials.gov ID
- NCT07047547
- Acronym / sponsor ID
- ESVGR-HF / 20250624
- Conditions
- Hemodialysis Complication, Heart Failure
- Keywords
- Vericiguat, Heart failure, Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vericiguat | Experimental | Drug: VericiguatUnder 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VericiguatUnder 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 |
Primary outcome
Left ventricular ejection fraction(LVEF)
Time frame: 12weeks
Change from baseline in left ventricular ejection fraction(LVEF)between baseline and end of study
Left ventricular ejection fraction (LVEF)
Time frame: 12weeks
Change from baseline in left ventricular ejection fraction (LVEF) between baseline and end of study
10 secondary outcomes
N terminal proB type natriuretic peptide (NT-prpBNP)
Time frame: 12 weeks
Left ventricular end diastolic volume (LVEDV)
Time frame: 12 weeks
Left atrial volume (LAV)
Time frame: 12 weeks
The ratio of mitral early diastolic blood flow peak and mitral annulus velocity (E/E')
Time frame: 12 weeks
Pulmonary Artery Pressure
Time frame: 12 weeks
Concentration of high-sensitivity serum troponin T
Time frame: 12 weeks
Minnesota Heart Failure Quality of Life Questionnaire (LiHFe)
Time frame: 12 weeks
Systolic and diastolic blood pressure
Time frame: 12 weeks
Electrocardiogram(ECG)
Time frame: 12 weeks
Estimated glomerular filtration rate(eGFR)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
Related trials for Hemodialysis Complication
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuangxin Liu principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vericiguat in people with Hemodialysis Complication and Heart Failure, run by Guangdong Provincial People's Hospital at 1 site 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Shuangxin Liu ((+86)020-83525210, gdphgcp@gdph.org.an), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction(LVEF) (time frame: 12weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2025.