Status:
RECRUITING
COgnitioN With VERiciGuat Evaluation in Heart Failure
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Canada
Conditions:
Heart Failure
Cognitive Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
- CMR exclusions: incompatible implantable cardiac device (ICD or CRT), uncontrolled atrial fibrillation or recurrent ventricular arrhythmias).
- 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.
Key Trial Info
Start Date :
June 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06601465
Start Date
June 3 2025
End Date
May 1 2027
Last Update
July 31 2025
Active Locations (4)
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1
University of Calgary
Calgary, Alberta, Canada
2
University of Alberta
Edmonton, Alberta, Canada
3
University of Ottawa
Ottawa, Ontario, Canada
4
McGill University Health Center
Montreal, Quebec, Canada