COgnitioN With VERiciGuat Evaluation in Heart Failure

NCT ID: NCT06601465

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-03

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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CONVERGE-HF is a randomized, open label, phase IIb trial evaluating the effect of sGC stimulator, Vericiguat versus standard of care on imaging markers and blood markers of cerebral and coronary small vessel diseases, function status, cognitive status, quality of life and clinical events in patients with heart failure and mild-to-moderate cognitive impairment. Patients will be randomized and allocated to either vericiguat or standard of care, for 26 weeks including the greater than 4 weeks timeframe for the uptitrations to the target dose.

Conditions

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Heart Failure Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vericiguat

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 Type EXPERIMENTAL

Vericiguat

Intervention Type DRUG

Tablet - 2.5 mg, 5 mg, 10 mg

Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vericiguat

Tablet - 2.5 mg, 5 mg, 10 mg

Intervention Type DRUG

Other Intervention Names

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Verquvo

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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)
2. Unable to undergo CMR imaging or brain MRI.
3. CMR exclusions: incompatible implantable cardiac device (ICD or CRT), uncontrolled atrial fibrillation or recurrent ventricular arrhythmias).
4. 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).
5. Patients with allergies to the study products.
6. Patients currently hospitalized.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role collaborator

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Ezekowitz, MBBCh, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

University of Ottawa

Ottawa, Ontario, Canada

Site Status RECRUITING

McGill University Health Center

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Justin Ezekowitz, MBBCh, MSc

Role: CONTACT

780-492-0712

Amanda Perreault, MSc

Role: CONTACT

780-492-5484

Other Identifiers

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CONVERGE-HF-2023-6

Identifier Type: -

Identifier Source: org_study_id

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