Vericiguat for people with heart failure and chronic kidney disease on dialysis

A Prospective, Observational, Single-arm Study to Evaluate the Efficacy and Safety of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure.

This study will try vericiguat in adults with chronic kidney disease who are on dialysis and have heart failure with reduced ejection fraction to see how it works and how well patients tolerate it.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 118 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07047547 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, single-arm study enrolling about 118 adults with chronic kidney disease and heart failure with reduced ejection fraction, many of whom are on dialysis. Participants will receive vericiguat and be followed in a real-world setting to record clinical events, tolerability, and treatment-related outcomes. The study targets patients with eGFR <90 ml/min/1.73 m2, NYHA class II or higher, LVEF ≤50%, and adequate dialysis adequacy (Kt/V>1.2 or URR>70%). Because randomized dialysis-specific trials are limited, this study aims to gather pragmatic safety and effectiveness data in this special population.

Who should consider this trial

Good fit: Adults aged 18–80 with chronic kidney disease (eGFR <90 ml/min/1.73 m2), chronic heart failure (NYHA ≥II) with LVEF ≤50%, acceptable potassium levels, and adequate dialysis (Kt/V>1.2 or URR>70%) are the intended participants.

Not a fit: Patients with acute renal failure, primary noncardiac causes of dyspnea or isolated right-sided heart failure, or systolic blood pressure below the study thresholds are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If results are favorable, vericiguat could offer a well-tolerated option that reduces heart-failure hospitalizations and cardiovascular risk for patients on dialysis.

How similar studies have performed: Vericiguat has shown benefit and tolerability in broader heart failure trials and is included in guidelines, but randomized or prospective data specifically in dialysis populations are lacking.

Eligibility criteria

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:

* 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.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Shuangxin Liu — Guangdong Provincial People's Hospital
• Study coordinator: Shuangxin Liu

Conditions Hemodialysis Complication; Heart Failure; Vericiguat; Heart failure