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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)

Primary Purpose

Chronic Heart Failure With Reduced Ejection Fraction, Worsening Heart Failure

Status
Recruiting
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Vericiguat (Verquvo, BAY1021189)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Krishna Institute of Medical Sciences Ltd.Recruiting
  • Max Super Speciality Hospital, SaketRecruiting
  • All India Institute of Medical SciencesRecruiting
  • Safdarjung HospitalRecruiting
  • Sanjivani Super Speciality HospitalRecruiting
  • Rhythm Heart InstituteRecruiting
  • Lisie HospitalRecruiting
  • Kokilaben Dhirubhai Ambani Hospital & Medical Research InstiRecruiting
  • Vijan Cardiac & Critical Care Centre
  • Deep HospitalRecruiting
  • Apollo Hospital TondiarpetRecruiting
  • Apollo Gleneagles Hospital LimitedRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vericiguat therapy

Arm Description

Adult participants with chronic HFrEF who are naïve to vericiguat and will be prescribed vericiguat as per local label by their treating physician (cardiologists).

Outcomes

Primary Outcome Measures

Occurrence of the composite of CV death or first hospitalization due to HF

Secondary Outcome Measures

Occurrence of CV death
Occurrence of first HF hospitalization
Occurrence of the composite of death due to all causes or first HF hospitalization
Occurrence of death due to all causes
Occurrence of adverse events (AEs), serious adverse events (SAEs), study interventionrelated AEs will be listed

Full Information

First Posted
December 12, 2022
Last Updated
October 11, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05658458
Brief Title
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)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
December 26, 2024 (Anticipated)
Study Completion Date
December 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure With Reduced Ejection Fraction, Worsening Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vericiguat therapy
Arm Type
Experimental
Arm Description
Adult participants with chronic HFrEF who are naïve to vericiguat and will be prescribed vericiguat as per local label by their treating physician (cardiologists).
Intervention Type
Drug
Intervention Name(s)
Vericiguat (Verquvo, BAY1021189)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Occurrence of CV death
Time Frame
14 days after end of treatment (EoT) visit (month 12) +1 week
Title
Occurrence of first HF hospitalization
Time Frame
14 days after end of treatment (EoT) visit (month 12) +1 week
Title
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
Title
Occurrence of death due to all causes
Time Frame
14 days after end of treatment (EoT) visit (month 12) +1 week
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bayer Clinical Trials Contact
Phone
(+)1-888-84 22937
Email
clinical-trials-contact@bayer.com
Facility Information:
Facility Name
Krishna Institute of Medical Sciences Ltd.
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 003
Country
India
Individual Site Status
Recruiting
Facility Name
Max Super Speciality Hospital, Saket
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110017
Country
India
Individual Site Status
Recruiting
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Safdarjung Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Sanjivani Super Speciality Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Individual Site Status
Recruiting
Facility Name
Rhythm Heart Institute
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390022
Country
India
Individual Site Status
Recruiting
Facility Name
Lisie Hospital
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682017
Country
India
Individual Site Status
Recruiting
Facility Name
Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400053
Country
India
Individual Site Status
Recruiting
Facility Name
Vijan Cardiac & Critical Care Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Deep Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141002
Country
India
Individual Site Status
Recruiting
Facility Name
Apollo Hospital Tondiarpet
City
Chennai
State/Province
Tamil N?du
ZIP/Postal Code
600081
Country
India
Individual Site Status
Recruiting
Facility Name
Apollo Gleneagles Hospital Limited
City
Kolkata
ZIP/Postal Code
700054
Country
India
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Learn more about this trial

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)

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