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Vericiguat for Heart Failure and Cognitive Impairment (CONVERGE-HF Trial)

Phase 2

Waitlist Available

Led By Justin Ezekowitz, MBBCh, MSc

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Established chronic heart failure (≥ 6 months)

Be older than 18 years old

Must not have

Patients currently hospitalized

Patients who have contraindications for sGC stimulator and vericiguat therapy (i.e. use of long-acting nitrates, other soluble guanylate cyclase stimulators (e.g., riociguat), or phosphodiesterase type 5 (PDE-5), pregnancy or breast-feeding)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new treatment for patients with chronic heart failure and mild-to-moderate memory problems."

Who is the study for?

This trial is for people who have had heart failure for at least 6 months and are also experiencing mild-to-moderate cognitive impairment. Specific eligibility criteria details are not provided.

What is being tested?

The CONVERGE-HF study is testing Vericiguat, a medication, to see if it can help patients with chronic heart failure and cognitive issues. It's a phase IIb trial conducted across four centers where participants are randomly chosen to receive the treatment.

What are the potential side effects?

Specific side effects of Vericiguat aren't listed here, but common ones may include dizziness, low blood pressure, or headaches based on its action in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had chronic heart failure for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently in the hospital.

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I am not using long-acting nitrates, sGC stimulators, PDE-5 inhibitors, and I am not pregnant or breastfeeding.

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I do not have severe kidney issues, incompatible heart devices, or uncontrolled heart rhythm problems.

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I do not have uncontrolled thyroid issues, liver failure, recent heart procedures, severe dementia, or active cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the lateral ventricular volumes.

Secondary study objectives

Blood Biomarkers (a)

Blood Biomarkers (b)

Clinical and patient-reported outcomes (6MWT)

+8 more

Side effects data

From 2019 Phase 3 trial • 5050 Patients • NCT02861534

15%

Hypotension

Dizziness

Anaemia

Cardiac failure

Nasopharyngitis

Dyspnoea

Diarrhoea

Pneumonia

Hyperkalaemia

Acute kidney injury

Chronic kidney disease

Syncope

Chronic obstructive pulmonary disease

Gastroenteritis

Sepsis

Ventricular tachycardia

Renal failure

Cardiac failure congestive

Cellulitis

Atrial fibrillation

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Vericiguat

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VericiguatExperimental Treatment1 Intervention

A starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. Uptitrated gradually every 2 weeks to 5 mg daily and then to the target dose of 10 mg daily.

Group II: Standard of CareActive Control1 Intervention

Conventional management of heart failure and mild-to-moderate cognitive impairment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vericiguat

2023

Completed Phase 4

~5080

0 / 5Eligibility criteria met