Vericiguat for people with heart failure and thinking problems.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jae2@ualberta.ca
• Phone: 780-492-0712

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.