Overview
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.
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 vessel diseases, function status, cognitive status, quality of life and clinical events in patients with heart failure and mild-to-moderate cognitive impairment. Patients will be randomized and allocated to either vericiguat or standard of care, for 26 weeks including the greater than 4 weeks timeframe for the uptitrations to the target dose.
Eligibility
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.