Study Results
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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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-06-03
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
Vericiguat
Tablet - 2.5 mg, 5 mg, 10 mg
Standard of Care
Conventional management of heart failure and mild-to-moderate cognitive impairment.
No interventions assigned to this group
Interventions
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Vericiguat
Tablet - 2.5 mg, 5 mg, 10 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ottawa Heart Institute Research Corporation
OTHER
Heart and Stroke Foundation of Canada
OTHER
University of Alberta
OTHER
Responsible Party
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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
University of Alberta
Edmonton, Alberta, Canada
University of Ottawa
Ottawa, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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CONVERGE-HF-2023-6
Identifier Type: -
Identifier Source: org_study_id
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