NCT07697833

Brief Summary

To compare the effectiveness and safety of Vericiguat with Standard Medical Treatment in Patients with Heart Failure and Reduced Ejection Fraction

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
12mo left

Started Jul 2026

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Jul 2027

First Submitted

Initial submission to the registry

June 30, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

June 30, 2026

Last Update Submit

July 10, 2026

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Keywords

VericiguatHeart FailureReduced Ejection Fraction (HFrEF)Chronic Heart FailureCardiovascular DiseasesRandomized Controlled TrialDouble BlindPlacebo-ControlledSoluble Guanylate Cyclase StimulatorNT-proBNP

Outcome Measures

Primary Outcomes (1)

  • Quality of life using Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated, patient-reported instrument that assesses health status, including symptoms, physical limitations, social limitations, and quality of life in patients with heart failure. The Overall Summary Score ranges from 0 to 100, with higher scores indicating better health status. The primary endpoint is the change in the KCCQ-12 Overall Summary Score from baseline to Month 6.

    Baseline to Month 6

Secondary Outcomes (1)

  • First Hospitalization for Heart Failure

    From enrollment to Month 6

Study Arms (2)

Treatment

EXPERIMENTAL

Vericiguat 10 mg (titrated from 2.5 mg, to 5 mg, and to 10 mg), on a background of standard of care

Drug: Vericiguat tablet

Placebo

PLACEBO COMPARATOR

Standard of care medications with placebo.

Drug: Placebo

Interventions

Vericiguat tabletDRUG

Vericiguat 10 mg (titrated from 2.5 mg, to 5 mg, and to 10 mg), on a background of standard of care

Also known as: VERIZOT
Treatment
PlaceboDRUG

Participants will receive a matching placebo tablet. The placebo will follow the same dosing schedule as the study drug (2.5 mg, 5 mg, and 10 mg) to maintain blinding.

Also known as: VERIZOT
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years of any gender
  • Chronic heart failure (New York Heart Association \[NYHA\] functional class II, III, or IV), a reduced left ventricular ejection fraction of less than 45% within 12 months before randomization
  • Elevated natriuretic peptide level: (For patients in sinus rhythm, the criteria include a plasma B-type natriuretic peptide (BNP) level of at least 300 pg per milliliter or an NT-proBNP level of at least 1000 pg per milliliter. For patients in atrial fibrillation, the criteria included a BNP level of at least 500 pg per milliliter or an NT-proBNP level of at least 1600 pg per milliliter).
  • Evidence of worsening heart failure.
  • The percentage of enrolled patients with an estimated glomerular filtration rate of 15 to 30 ml per minute per 1.73 m2 of body-surface area was capped at 15%.
  • Patients on guideline-based medical therapy 3 months
  • Written and informed consent.

You may not qualify if:

  • Systolic blood pressure of less than 100 mm Hg.
  • Concurrent or anticipated use of long-acting nitrates.
  • Use of intravenous inotropes or implantable left ventricular assist devices.
  • Not on standard of care medical treatment for heart failure.
  • Unwillingness to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureCardiovascular Diseases

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • Ghazala Irfan, FCPS

    National Institute of Cardiovascular Diseases Karachi, Pakistan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghazala Irfan, FCPS

CONTACT

+92 3002167206ghazala.irfan@gmail.com

Reema Qayoom, FCPS

CONTACT

+92 3333864264dr.reemaqayoom@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 13, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share