Trial to evaluate vericiguat therapy in heart failure patients.

Phase 4

• Conditions: Health Condition 1: I508- Other heart failure

• Registration Number: CTRI/2022/11/047636
• Lead Sponsor: Bayer Zydus Pharma Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the health outcomes in patients <br/ ><br>treated with vericiguat following a hospitalization or need for iv diuretic treatment after WHF. <br/ ><br>Endpoint: Occurrence of the composite of cardiovascular (CV) death or first hospitalization due to HF.Timepoint: From Day 1 to Week 48±2 weeks.