A RANDOMIZED PARALLEL-GROUP, PLACEBO-CONTROLLED, DOUBLE-BLIND, EVENT-DRIVEN, MULTI-CENTER PIVOTAL PHASE III CLINICAL OUTCOME TRIAL OF EFFICACY AND SAFETY OF THE ORAL SGCSTIMULATOR VERICIGUAT IN SUBJECTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION(HFREF) - VERICIGUAT GLOBAL STUDY IN SUBJECTS WITH HEART FAILURE WITH REDUCED EJECTIONFRACTION (VICTORIA)

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,0 个研究点目标入组 59 人开始时间: 2017年12月26日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. Provide written informed consent for the trial. 2. Be male or female, aged 18 years or older on the day of signing informed consent. 3. Have a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying
•HF decompensation.4. Have a previous HF hospitalization within 6 months prior to randomization or IV diuretic
•treatment for HF (without hospitalization) within 3 months prior to randomization. 5. Have brain natriuretic peptide (BNP) or NT-proBNP levels within 30 days prior to randomization as per protocol. 6. Have a left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior to randomization by any method (most recent measurement must be used to determine eligibility).7 The subject is a male. The subject is a female who is not of reproductive potential. The subject is a female who is of reproductive potential and agrees to avoid
•becoming pregnant

•1. Is clinically unstable at the time of randomization as defined by: Administration of any intravenous treatment within 24 hours prior to randomization, and/or Systolic blood pressure (SBP) <100 mmHg or symptomatic hypotension.
•2. Has concurrent or anticipated use of long-acting nitrates or NO donors including
•isosorbide dinitrate, isosorbide 5-mononitrate, and others. 3. Has concurrent use or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil.
•4. Has concurrent use or anticipated use of a sGC stimulator such as riociguat. 5. Has known allergy or sensitivity to any sGC stimulator. 6. Is awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B or
•equivalent), receiving continuous IV infusion of an inotrope, or has/anticipates
•receiving an implanted ventricular assist device. 7. Has primary valvular heart disease requiring surgery or intervention, or is within 3 months after valvular surgery or intervention. 8. Has hypertrophic obstructive cardiomyopathy. 9. Has acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy.
•10. Has post-heart transplant cardiomyopathy. And Others. For more information please refer to the protocol

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,