Study Completed

Chronic heart failure with reduced ejection fraction, Worsening heart failure

Bayer Identifier:

22144

ClinicalTrials.gov Identifier:

NCT05658458

EudraCT Number:

Not Available

EU CT Number:

Not Available

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)

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A

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.

Trial summary

Enrollment Goal

205

Trial Dates

December 2022 - September 2024

Phase

Phase 4

Could I Receive a placebo

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Active, not recruiting	Vijan Cardiac & Critical Care Centre	Nashik, 422005, India
Active, not recruiting	Rhythm Heart Institute	Vadodara, 390022, India
Active, not recruiting	Deep Hospital	Ludhiana, 141002, India
Completed	Sanjivani Super Speciality Hospital	Ahmedabad, 380015, India
Completed	Apollo Gleneagles Hospital Limited	Kolkata, 700054, India
Active, not recruiting	Lisie Hospital	Kochi, 682017, India
Completed	Apollo Hospital Tondiarpet	Chennai, 600081, India
Completed	Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti	Mumbai, 400053, India
Active, not recruiting	Max Super Speciality Hospital, Saket	New Delhi, 110017, India
Active, not recruiting	All India Institute of Medical Sciences	Bhubaneswar, 751019, India
Active, not recruiting	Safdarjung Hospital	New Delhi, 110029, India
Active, not recruiting	Krishna Institute Of Medical Science	Secunderabad, 500 003, India

Primary Outcome

Occurrence of the composite of CV death or first hospitalization due to HF
Time Frame:
14 days after end of treatment (EoT) visit (month 12) +1 week

Secondary Outcome

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

Trial design

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.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

N/A

Assignment

Single Group Assignment

Trial Arms