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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Tablet - 2.5 mg, 5 mg, 10 mg
University of Calgary
Calgary, Alberta, Canada
RECRUITINGUniversity of Alberta
Edmonton, Alberta, Canada
RECRUITINGUniversity of Ottawa
Ottawa, Ontario, Canada
RECRUITINGChange in the lateral ventricular volumes.
To determine whether in patients with heart failure and mild-to-moderate cognitive impairment, the 26 weeks of treatment with sGC stimulator, vericiguat versus standard of care lead to greater reduction (or smaller increase) in lateral ventricular volume in brain MRI as a proxy for the preservation of brain microvasculature and preventing brain tissue loss.
Time frame: 26 weeks
Blood Biomarkers (a)
To determine the difference in the change in cardiac ischemia and strain markers measured by cardiac troponin, IGFBP-7, and NT-proBNP between patients with heart failure and mild-to-moderate cognitive impairment who were treated for 26 weeks with sGC stimulator, vericiguat versus standard of care.
Time frame: 26 weeks
Blood Biomarkers (b)
To determine the difference in the change of brain-related marker of cis p-tau between patients with chronic CV disease and mild-to-moderate cognitive impairment who were treated for 26 weeks with sGC stimulator, vericiguat versus standard of care.
Time frame: 26 weeks
Imaging Biomarkers (Cardiac)
To determine the difference between patients with heart failure and mild-to-moderate cognitive impairment who were treated for 26 weeks with sGC stimulator, vericiguat, versus standard of care in terms of the change in CMR perfusion test results for perfusion deficits indicative of coronary microvascular impairment.
Time frame: 26 weeks
Imaging Biomarkers (Brain)
To determine the difference between patients with heart failure and mild-to-moderate cognitive impairment who were treated for 26 weeks with sGC stimulator, vericiguat versus standard of care in terms of the change in brain MRI peak skeletonized mean diffusivity of the white matter and change in white matter hypersensitivity volume indicative of cerebral small vessel disease.
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McGill University Health Center
Montreal, Quebec, Canada
NOT_YET_RECRUITINGTime frame: 26 weeks
Clinical and patient-reported outcomes (MoCA)
To compare the change of MoCA scores in 26 weeks between groups who were treated with vericiguat versus standard of care.
Time frame: 26 weeks
Clinical and patient-reported outcomes (KCCQ-12)
To compare the change of health-related quality of life (assessed via KCCQ-12) in 26 weeks between groups who were treated with vericiguat versus standard of care. The KCCQ-12 has a standardized format and has been validated for paper, electronic or telephone delivery.
Time frame: 26 weeks
Clinical and patient-reported outcomes (6MWT)
To compare the change of functional status assessed via 6-minute walk test (6MWT) in 26 weeks between groups who were treated with vericiguat versus standard of care. The 6MWT will be performed as outlined by the American Thoracic Society by an assessor blinded to treatment allocation.61 6MWT will be assessed both in-person and using the validated virtual approach utilizing Walk.Talk.Track app.
Time frame: 26 weeks
Clinical and patient-reported outcomes (RBANS)
To compare the change of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores between groups. The RBANS is a widely-used battery for identifying and characterizing abnormal cognitive decline in elderly adults. Its level of difficulty is appropriate for the range from normal cognition to moderately severe dementia.
Time frame: 26 weeks
Clinical events - Death
(all cause)
Time frame: 26 weeks
Clinical events - Hospitalizations
(all cause)
Time frame: 26 weeks
Clinical events - Emergency Department Visits
(all cause)
Time frame: 26 weeks
Clinical events - Stroke
Time frame: 26 weeks
Clinical events - Other
Time frame: 26 weeks