Status and phase
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Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention
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Inclusion criteria
Exclusion criteria
Myocardial infarction, stroke or transient cerebral ischaemic attack, sustained ventricular tachycardia or ventricular fibrillation within 1 month prior to screening; or severe infection, major trauma or undergoing major or medium-sized surgery within 1 month prior to screening;
Coronary revascularisation (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), atrial flutter/fibrillation ablation, pacemaker implantation, valve repair/replacement, carotid or peripheral artery revascularisation, cardiac mechanical assist device therapy, heart transplantation within 1 month prior to screening or planned during the trial; or current severe coronary artery disease or cerebrovascular disease without revascularisation;
Fluid retention symptoms and signs judged by the investigator to be caused by non-cardiac diseases; or concomitant conditions causing dyspnoea or fluid retention, such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary heart disease, severe anaemia, decompensated liver cirrhosis, nephrotic syndrome, etc.;
Acute heart failure requiring primary correction of the underlying cause as determined by the investigator, due to the following conditions: coronary atherosclerotic heart disease requiring revascularisation, active myocarditis, constrictive pericarditis, cardiac tamponade, complex congenital heart disease, untreated severe primary valvular heart disease, etc.;
Previously diagnosed hypertrophic cardiomyopathy (obstructive or non-obstructive), amyloid cardiomyopathy;
Use of cardiac mechanical assist device at the time of screening;
Hypovolaemia or peripheral perfusion insufficiency at the time of screening, requiring vasoactive drugs, positive inotropic drugs or volume expansion therapy as assessed by the investigator;
Anuria at the time of screening; or urinary difficulties caused by urinary tract obstruction, stones or tumours;
Unable to perceive thirst at the time of screening, or any reason causing difficulty in fluid intake;
Unable to complete weight measurement or urine collection;
Consciousness impairment at the time of screening, or hepatic encephalopathy at the time of screening or a history of hepatic encephalopathy;
Poorly controlled diabetes at the time of screening, with fasting blood glucose ≥11.1mmol/L;
Any organ system malignancy within the last 5 years requiring ongoing treatment such as chemotherapy, radiotherapy, endocrine therapy, targeted therapy, etc.;
History of drug abuse or substance use within 1 year prior to screening.
Body mass index (BMI) less than 18.5 or greater than 35 kg/m2;
Symptomatic hypotension and/or systolic blood pressure <90 mmHg;
Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI2009] formula based on serum creatinine), or undergoing/planned for haemodialysis or ultrafiltration therapy;
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3× the upper limit of normal (ULN), except if assessed by the investigator as due to heart failure;
Serum sodium > ULN or <130 mmol/L;
Serum potassium > ULN or serum potassium still < lower limit of normal (LLN) after treatment;
Concurrent active hepatitis B (hepatitis B surface antigen [HBsAg] positive and peripheral blood hepatitis B virus DNA positive) or any one of human immunodeficiency virus antibodies (HIV-Ab), Treponema pallidum antibodies (Anti-TP), hepatitis C virus antibodies (HCV-Ab) positive.
Known or suspected allergy to tolvaptan tablets, OPC-61815 injection, or HRS-9057 injection components;
Participation in any drug or medical device clinical trial within 3 months prior to screening, defined as: signing the informed consent and using the investigational product (excluding placebo) or investigational medical device; or still within 5 half-lives of the investigational drug (whichever is longer);
Use of tolvaptan tablets, OPC-61815 injection, or thiazide diuretics (including combination formulations) within 5 half-lives before dosing;
Use of drugs that may affect tolvaptan metabolism within 2 weeks or 5 half-lives before dosing (whichever is longer), includin
ⅰ strong or moderate CYP3A inhibitors: ketoconazole or other strong CYP3A inhibitors (such as clarithromycin, itraconazole, telithromycin, saquinavir, nelfinavir, ritonavir, nefazodone), moderate CYP3A inhibitors (such as erythromycin, fluconazole, aprepitant, diltiazem, verapamil, delavirdine);
ⅱ CYP3A inducers: rifampicin or other inducers (such as rifabutin, rifapentine, barbiturates, phenytoin, carbamazepine, forsythia);
ⅲ P-glycoprotein inhibitors: such as cyclosporine;
History of blood donation or blood loss ≥400 mL within 3 months prior to screening, or blood transfusion within 2 months;
Participants with mental incapacity or speech disorders, or unable to fully understand or participate in the trial process, or unable to fully understand potential adverse reactions during the study;
Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use protocol-specified contraception during the trial and for 1 week after the last dose;
As judged by the investigator, any condition affecting participant safety or otherwise interfering with the evaluation of trial results (medical, psychological, social, or geographical factors, etc.).
Primary purpose
Allocation
Interventional model
Masking
118 participants in 2 patient groups, including a placebo group
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Central trial contact
Na Li
Data sourced from clinicaltrials.gov
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