COgnitioN With VERiciGuat Evaluation in Heart Failure
Recruiting · NCT06601465 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
4 locations listed.
- 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