Clinical trial NCT05658458: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure With Reduced Ejection Fraction
Worsening Heart Failure
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Occurrence of the composite of CV death or first hospitalization due to HF
timeFrame: 14 days after end of treatment (EoT) visit (month 12) +1 week
Secondary outcomes:
measure: Occurrence of CV death
timeFrame: 14 days after end of treatment (EoT) visit (month 12) +1 week
measure: Occurrence of first HF hospitalization
timeFrame: 14 days after end of treatment (EoT) visit (month 12) +1 week
measure: Occurrence of the composite of death due to all causes or first HF hospitalization
timeFrame: 14 days after end of treatment (EoT) visit (month 12) +1 week
measure: Occurrence of death due to all causes
timeFrame: 14 days after end of treatment (EoT) visit (month 12) +1 week
measure: Occurrence of adverse events (AEs), serious adverse events (SAEs), study interventionrelated AEs will be listed
timeFrame: 14 days after end of treatment (EoT) visit (month 12) +1 week
Other outcomes:
Locations:
city: Secunderabad
country: India
facility: Krishna Institute Of Medical Science
state: Andhra Pradesh
city: New Delhi
country: India
facility: Max Super Speciality Hospital, Saket
state: Delhi
city: New Delhi
country: India
facility: Safdarjung Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Sanjivani Super Speciality Hospital
state: Gujarat
city: Vadodara
country: India
facility: Rhythm Heart Institute
state: Gujarat
city: Kochi
country: India
facility: Lisie Hospital
state: Kerala
city: Mumbai
country: India
facility: Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti
state: Maharashtra
city: Nashik
country: India
facility: Vijan Cardiac & Critical Care Centre
state: Maharashtra
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences
state: Odisha
city: Ludhiana
country: India
facility: Deep Hospital
state: Punjab
city: Chennai
country: India
facility: Apollo Hospital Tondiarpet
state: Tamil N?du
city: Kolkata
country: India
facility: Apollo Gleneagles Hospital Limited
Study officials:
References: