Health Condition 1: I508- Other heart failure
Conditions
Interventions
Intervention1: Vericiguat: The participants in the study will start the treatment with the study drug at a dose of 2.5 mg once daily orally, taken with food. The dose of the study drug will be doubled
within 30 days after the start of the Screening visit), the participants will be assigned the study drug after all procedures specified for this visit will be done.
ï?§ Follow up visits are Visit 3 (D
Sponsors
Bayer Zydus Pharma Private Limited
Eligibility
Inclusion criteria
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 ( 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
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) 2. Participation in another interventional clinical study and treatment with another investigational product 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the health outcomes in patients treated with vericiguat following a hospitalization or need for iv diuretic treatment after WHF. Endpoint: Occurrence of the composite of cardiovascular (CV) death or first hospitalization due to HF.Timepoint: From Day 1 to Week 48±2 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome: To evaluate: 1. CV mortality 2. First hospitalization due to HF 3. Composite of all-cause mortality and first HF hospitalization 4. All-cause mortality 5. Safety Endpoints: 1. Occurrence of CV death 2. Occurrence of first HF hospitalization. 3. Occurrence of the composite of death due to all causes or first HF hospitalization. 4. Occurrence of death due to all causes. 5. Occurrence of adverse events (AEs), serious adverse events (SAEs), and study intervention related AEs will be listed. Tertiary outcome: To evaluate: 1. Titration management (initial titration) 2. Treatment pattern of vericiguat 3. Total hospitalizations due to HF Endpoint: 1. Time to reach different dose levels of vericiguat (2.5 mg, 5 mg, or 10 mg) during initial titration 2. Relative time on different dose levels of vericiguat (2.5 mg, 5 mg, or 10 mg) during follow-up 3. Total number of hospitalizations due to HF Timepoint: From Day 1 to Week 48±2 weeks. | — |
Countries
India
Contacts
Public ContactDr Smruti Jagtap
Bayer Zydus Pharma Private Limited
Outcome results
None listed