A Phase IV interventional post approval trial to investigate effectiveness and safety of vericiguat therapy in Indian patients with chronic heart failure with reduced ejection fraction after a worsening heart failure event. - VERINA

Bayer Zydus Pharma Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1. Male or female participants aged >=18 years at the time point of signing informed consent form (ICF).
•2. Has a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying HF decompensation.
•3. Has chronic HF with reduced LVEF ( <45%) after a WHF event (defined as HF hospitalization or use of iv diuretics for HF [without hospitalization]).
•4. Is capable of giving signed ICF and willing to comply with the study-related procedures.
•5. Female participants in the following categories:
•5.1 A female who is not of reproductive potential, defined as a female who either: (a) is postmenopausal (defined as at least 12 months with no menses in women >=45 years of age); (b) has had a hysterectomy and/or bilateral oophorectomy,
•bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to Screening; or (c) has a congenital or acquired condition that prevents childbearing
•5.2. A female who is of reproductive potential and agrees to avoid becoming pregnant while receiving the study drug and for 14 days after the last dose of the study drug by complying with one of the following: (a) practice abstinence from
•heterosexual activity or (b) use (and have her partner use) highly effective contraception method during heterosexual activity.

•1. Participants who are clinically unstable at the time of screening defined by administration of any iv treatment within 24 hours until start of study intervention, and/or systolic blood pressure (SBP) < 100 mmHg or symptomatic hypotension
•2. Participation in another interventional clinical study and treatment with another
•investigational product <=30 days prior to screening
•3. Concurrent use of phosphodiesterase type 5 (PDE5) inhibitors, or a soluble guanylate
•cyclase (sGC) stimulator, such as riociguat
•4. Known allergy or hypersensitivity to any sGC stimulator
•5. Severe hepatic insufficiency such as with hepatic encephalopathy
•6. Severe renal impairment with eGFR < 15 mL/min/1.73m2(calculated based on the
•Modification of Diet in Renal Disease [MDRD] equation) or on dialysis
•7. Is pregnant or breast feeding or plans to become pregnant or to breastfeed during the
•course of the trial

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