The Effect of Sacubitril/Valsartan on Cardiovascular Events in Dialysis Patients and Efficacy Pre… (NCT04572724) | Clinical Trial Compass
UnknownPhase 4
The Effect of Sacubitril/Valsartan on Cardiovascular Events in Dialysis Patients and Efficacy Prediction of Baseline LVEF Value
China120 participantsStarted 2020-07-06
Plain-language summary
Patients with end stage renal disease (ESRD), especially after having maintenance dialysis are among the highest risk of heart failure (HF), which is the most important cause that affects survival rate and quality of life. Sacubitril/Valsartan is recommended as a first-line option for treating symptomatic chronic heart failure, especially HF with reduced ejection fraction (HFrEF). Sacubitril/Valsartan was reported the different effectiveness in HFrEF and HF with preserved ejection fraction (HFpEF), and the clinical trials' results are controversial in HFpEF patients. So far, there have been seven clinical trials (or subgroups of trials) that used sacubitril/valsartan in heart failure patients with chronic kidney disease, only one retrospective study to evaluate the improvement of cardiovascular biomarkers and LVEF in hemodialysis patients who have HFrEF. In addition, there is no article predicting the outcomes of Sacubitril/Valsartan, the inclusion criteria of LVEF value are not consistent. Investigators will perform a prospective, cohort study to evaluate the efficacy and safety of Sacubitril/Valsartan on Cardiovascular Events Outcome in Maintenance hemodialysis and peritoneal dialysis patients with Heart Failure, and use secondary analysis to find out the range of baseline LVEF Value to predict the therapeutic effects.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 70 years old participants, No restrictions on gender or race
* Stable heart failure in New York Heart Association (NYHA) class II, III, or IV symptoms, presentation of typical heart failure symptoms accompanied by HF signs caused by a structural and/or functional cardiac abnormality
* Under maintenance dialysis (hemodialysis or peritoneal dialysis) for more than one year
* Patients have a plasma N-terminal pro-BNP (NT-proBNP) level ≥600 pg per milliliter, or if they had been hospitalized for heart failure within the previous 12 months, an NT-proBNP ≥400 pg per milliliter
* Patients written informed consent
Exclusion Criteria:
* Repeatedly symptomatic hypotension, systolic blood pressure of less than 90 mmHg and diastolic blood pressure of less than 60 mmHg, which cannot tolerate the RASS inhibitors therapy
* Patients who have significant fluid overload and did not reach dry weight stably
* Patients with acute myocardial infarction or implantation of intracoronary stents, coronary artery bypass grafting (CABG) and pacemaker within three months
* Patients with special type of heart disease, including cardiac amyloidosis, congential heart disease and pericardial disease
* Patients with malignant hypertension and hypertensive emergencies that can not be controlled
* Patients with significant impaired liver function
* Patients with repeatedly or server infection
* Allergic to the trial drugs
* Unacceptable side effects during receipt of RASS inhibito…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 4 trial testing sacubitril/valsartan — a drug already approved for heart failure — what do we know so far about how safe it is specifically for people on dialysis, given that kidney function plays a big role in how the body handles this medication?
2The trial is looking at whether a patient's baseline ejection fraction (LVEF) predicts how well sacubitril/valsartan works — does my current ejection fraction suggest I might be a good or poor responder based on what the researchers are trying to find out?
3This trial is tracking cardiovascular events and hospitalizations for heart failure as its main goals — given my specific situation on dialysis, do you think my risk for those outcomes is high enough that joining a study like this might make sense compared to just staying on my current treatment plan?
4The trial's recruitment status is listed as unknown, so could you help me find out whether this study is still actively enrolling patients, and if not, are there similar trials or treatment options I should be considering instead?
5Since I'm already managing either peritoneal dialysis or hemodialysis alongside heart failure, how would participating in a study with regular monitoring and possibly adding sacubitril/valsartan fit into my current care schedule, and would it be too demanding given everything else I'm already doing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.