BridgeMD
New treatment option for Hemodialysis Complication
Official title A Study of Real-world Events of Vericiguat in Patients With Chronic Kidney Disease and Heart Failure
ClinicalTrials.gov ID: NCT07047547
What this study is testing
What is Vericiguat?
Vericiguat is an investigational medicine, being studied as a potential treatment for hemodialysis complication.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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 how well it works of the study drug (e.g., serum potassium \> 5.5 mmol/L or \ 2 times the upper limit of the normal...
- 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...
- Pregnant or breastfeeding during the study period, or intending to become pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.