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Comparing the Efficacy and Safety of Vericiguat With Standard Medical Treatment in Heart Failure Patients

ConditionHeart Failure With Reduced Ejection Fraction (HFrEF)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Institute of Cardiovascular Diseases, Pakistan

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vericiguat tablet

    Drug

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

  • Placebo

    Drug

    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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to Month 6

Secondary outcomes

1

First Hospitalization for Heart Failure

Time to first hospitalization for worsening heart failure during the study follow-up.

Time frame
From enrollment to Month 6

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Cardiovascular Diseases, Pakistan

Lead sponsor

Horizon Pharmaceuticals

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: