COgnitioN With VERiciGuat Evaluation in Heart Failure

NCT06601465 | Recruiting Phase 2 DMC

• 1 other identifier: CONVERGE-HF-2023-6
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

CONVERGE-HF is a 4-center pilot phase IIb randomized control trial in ambulatory patients with chronic heart failure (≥ 6 months) and mild-to-moderate cognitive impairment.

Conditions

Heart Failure; Cognitive Impairment

Keywords

Heart Failure; Cognitive Impairment; Vericiguat

Outcome Measures

Primary Outcomes (1)

• Change in the lateral ventricular volumes.

  To determine whether in patients with heart failure and mild-to-moderate cognitive impairment, the 26 weeks of treatment with sGC stimulator, vericiguat versus standard of care lead to greater reduction (or smaller increase) in lateral ventricular volume in brain MRI as a proxy for the preservation of brain microvasculature and preventing brain tissue loss.

  26 weeks

Secondary Outcomes (13)

• Blood Biomarkers (a)

  26 weeks

• Blood Biomarkers (b)

  26 weeks

• Imaging Biomarkers (Cardiac)

  26 weeks

• Imaging Biomarkers (Brain)

  26 weeks

• Clinical and patient-reported outcomes (MoCA)

  26 weeks

Study Arms (2)

Vericiguat

EXPERIMENTAL

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.

Drug: Vericiguat

Standard of Care

NO INTERVENTION

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

Interventions

Vericiguat DRUG

Tablet - 2.5 mg, 5 mg, 10 mg

Also known as: Verquvo

Vericiguat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• Established chronic heart failure (≥ 6 months)
• Mild-to-moderate cognitive impairment (as per the diagnosis of cognitive impairment or a Montreal Cognitive Assessment (MoCA) score 10-25).

You may not qualify if:

• 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)
• Unable to undergo CMR imaging or brain MRI.
• General medical conditions: uncontrolled thyroid disorders, hepatic failure, or myocardial revascularization procedures \[coronary angioplasty and/or surgical revascularization in the previous 3 months\], cancer/malignancy, or with severe dementia).
• Patients with allergies to the study products.
• Patients currently hospitalized.

Sponsors & Collaborators

• University of Alberta: lead
• Ottawa Heart Institute Research Corporation: collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (4)

University of Calgary

Calgary, Alberta, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

University of Ottawa

Ottawa, Ontario, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Justin Ezekowitz, MBBCh, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Ezekowitz, MBBCh, MSc

CONTACT

780-492-0712; jae2@ualberta.ca

Amanda Perreault, MSc

CONTACT

780-492-5484; aperreau@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)