Vericiguat for people with heart failure and thinking problems.

CONVERGE-HF: COgnitioN With VERiciGuat Evaluation in Heart Failure

This trial will test whether adding vericiguat to usual care helps brain blood-vessel health and improves thinking and function in adults with chronic heart failure and mild-to-moderate cognitive impairment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 4 sites (Calgary, Alberta and 3 other locations)
• Trial ID: NCT06601465 on ClinicalTrials.gov

What this trial studies

CONVERGE-HF is a randomized, open-label phase IIb pilot trial at four Canadian centers enrolling ambulatory adults with chronic heart failure of at least six months and mild-to-moderate cognitive impairment. Participants are randomized to vericiguat plus usual care or to usual care alone for 26 weeks, including a more-than-four-week uptitration period to reach target dose. Outcomes include imaging and blood markers of cerebral and coronary small-vessel disease, cognitive testing, functional status, quality of life, and clinical events. The trial aims to determine whether soluble guanylate cyclase stimulation with vericiguat leads to measurable vascular and cognitive benefits in this population.

Who should consider this trial

Good fit: Ideal candidates are ambulatory adults with chronic heart failure (≥6 months) and mild-to-moderate cognitive impairment (MoCA score 10–25) who can undergo brain and cardiac MRI and are not taking contraindicated medications.

Not a fit: Patients with severe dementia, incompatible cardiac implants or MRI contraindications, recent coronary revascularization, pregnancy, or who require long-acting nitrates or PDE5 inhibitors are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could improve brain small-vessel health, cognitive function, and heart-related outcomes for people with heart failure.

How similar studies have performed: Previous large trials of vericiguat in heart failure have shown modest reductions in heart-failure events, but its effects on brain small-vessel disease and cognition remain largely untested.

Eligibility criteria

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.

Where this trial is running

Calgary, Alberta and 3 other locations

• 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)

Study contacts

• Principal investigator: Justin Ezekowitz, MBBCh, MSc — University of Alberta
• Study coordinator: Justin Ezekowitz, MBBCh, MSc

Conditions Heart Failure; Cognitive Impairment; Vericiguat