A Study to Learn How Well the Drug Vericiguat Works and How Safe it is Under Real World Conditions in Indian Participants After Worsening of a Long-term Heart Condition in Which the Left Side of the Heart Does Not Pump Blood as Well as it Should (Chronic Heart Failure With Reduced Ejection Fraction)

Chronic Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658458
• Other study ID #: 22144
• Status: Recruiting
• Phase: Phase 4
• Start date: December 16, 2022
• Est. completion date: December 26, 2024

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and death. Despite various available treatments for long-term HFrEF, people may experience worsening of their condition, called worsening heart failure events. Worsening heart failure events require the patient to either stay in the hospital or receive special treatment to remove excess water from the body. The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps to regulate the heart and blood circulation. Vericiguat was recently approved in India for doctors to prescribe to people with HFrEF after they had a worsening heart failure event, with a request to specifically gather information on vericiguat therapy in Indians. Therefore, the main purpose of this study is to learn more about how well vericiguat works in Indian people with HFrEF who receive vericiguat after a worsening heart failure event. Work well means to prevent: - death due to heart and circulatory events, or - hospital stays. Researchers will collect the number of participants treated with vericiguat who have either of this. To find out how safe vericiguat is, researchers will also collect the number of participants who have medical problems during the study. Doctors keep track of all medical problems, even if they do not think the adverse events might be related to the study treatments. The participants will take vericiguat as tablet by mouth and as prescribed by their doctors according to the local label. Each participant will be in the study for approximately 1 year including a screening period of up to 1 month. Up to 8 visits to the study site are planned. During the study, the study team will: - check vital signs - do physical examinations - examine heart health using electrocardiogram ECG and if needed echocardiography - take blood and urine samples

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 26, 2024
• Est. primary completion date: December 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female participants aged =18 years at the time point of signing ICF
• Has a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying HF decompensation
• Has chronic HF with reduced LVEF (<45%) after a WHF event (defined as HF hospitalization or use of iv diuretics for HF [without hospitalization])
• Is capable of giving signed ICF and willing to comply with the study-related procedures
• Female participants in the following categories:
• 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

• 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) acceptable, highly effective contraception methods during heterosexual activity.

Exclusion Criteria:

• Is clinically unstable at the time of screening defined by:
• Administration of any iv treatment within 24 hours until start of study intervention, and/or
• SBP < 100 mmHg or symptomatic hypotension.
• Has concurrent or anticipated use of PDE5 inhibitors, or a sGC stimulator such as riociguat.
• Has known allergy or hypersensitivity to any sGC stimulator.
• Has severe hepatic insufficiency such as with hepatic encephalopathy.
• Has severe renal impairment with eGFR < 15 mL/min/1.73m*2 (calculated based on the MDRD equation) or on dialysis.
• Is pregnant or breast feeding or plans to become pregnant or to breastfeed during the course of the trial.
• Participated in another interventional clinical study and treatment with another investigational product = 30 days prior to screening.

Related Conditions & MeSH terms

• Chronic Heart Failure With Reduced Ejection Fraction
• Heart Failure

Intervention

Drug:
• Vericiguat (Verquvo, BAY1021189)
The recommended starting dose of vericiguat is 2.5 mg once daily, taken with food. The dose of vericiguat would be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the participant.

Locations

Country	Name	City	State
India	Sanjivani Super Speciality Hospital	Ahmedabad	Gujarat
India	All India Institute of Medical Sciences	Bhubaneswar	Delhi
India	Apollo Hospital Tondiarpet	Chennai	Tamil N?du
India	Lisie Hospital	Kochi	Kerala
India	Apollo Gleneagles Hospital Limited	Kolkata
India	Deep Hospital	Ludhiana	Punjab
India	Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti	Mumbai	Maharashtra
India	Vijan Cardiac & Critical Care Centre	Nashik	Maharashtra
India	Max Super Speciality Hospital, Saket	New Delhi	Delhi
India	Safdarjung Hospital	New Delhi	Delhi
India	Krishna Institute of Medical Sciences Ltd.	Secunderabad	Andhra Pradesh
India	Rhythm Heart Institute	Vadodara	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of the composite of CV death or first hospitalization due to HF		14 days after end of treatment (EoT) visit (month 12) +1 week
Secondary	Occurrence of CV death		14 days after end of treatment (EoT) visit (month 12) +1 week
Secondary	Occurrence of first HF hospitalization		14 days after end of treatment (EoT) visit (month 12) +1 week
Secondary	Occurrence of the composite of death due to all causes or first HF hospitalization		14 days after end of treatment (EoT) visit (month 12) +1 week
Secondary	Occurrence of death due to all causes		14 days after end of treatment (EoT) visit (month 12) +1 week
Secondary	Occurrence of adverse events (AEs), serious adverse events (SAEs), study interventionrelated AEs will be listed		14 days after end of treatment (EoT) visit (month 12) +1 week