Clinical trial NCT04572724: The Effect of Sacubitril/Valsartan on Cardiovascular Events in Dialysis Patients and Efficacy Prediction of Baseline LVEF Value
Official title: The Effect of Sacubitril/Valsartan on Cardiovascular Events Outcome in Maintenance Dialysis Patients With Heart Failure and Efficacy Prediction of Baseline LVEF Value：A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peritoneal Dialysis Complication
Hemodialysis Complication
Heart Failure
Keywords: Sacubitril/valsartan
Peritoneal dialysis
Hemodialysis
Cardiovascular Events
Efficacy Prediction
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants who met the inclusion and exclusion criteria will enrolled in the trial. Subjects will be divided into two groups (1:1 matching will be achieved after a screening of propensity score) to receive one of two interventions in addition to standard HF management: Sacubitril/Valsartan group or RAS inhibitor group.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The trial will examine the effect of Sacubitril/Valsartan on cardiovascular events in HF patients receiving maintenance hemodialysis or peritoneal dialysis. Subjects will be divided into two groups (1:1 matching will be achieved after a screening of propensity score) to receive one of two interventions in addition to standard HF management: Sacubitril/Valsartan group or RAAS inhibitor group. All subjects can have a beta-blocker, CCB, and/or alpha-blockers to control BP. Dialysis treatment: patients normally complete hemodialysis or peritoneal dialysis, need to ensure adequate dialysis requirements, no obvious overload, patients achieve dry weight after dialysis.

Participants will be treated and follow-up for at least 18 months.

Eligibility criteria: 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 inhibitors
* Pregnancy
* Patients who are unable to provide informed consent

Primary outcomes:
measure: cardiovascular events
timeFrame: at least 18 months
measure: hospitalization for heart failure
timeFrame: at least 18 months
Secondary outcomes:
measure: change rate of cardiovascular events
timeFrame: at least 18 months
measure: NT-proBNP
timeFrame: 12 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 1month, 6month,18 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: YI XU
role: PRINCIPAL_INVESTIGATOR
References: