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| Name | Class |
|---|---|
| Ottawa Heart Institute Research Corporation | OTHER |
| Heart and Stroke Foundation of Canada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vericiguat | Experimental | A starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. Uptitrated gradually every 2 weeks to 5 mg daily and then to the target dose of 10 mg daily. |
|
| Standard of Care | No Intervention | Conventional management of heart failure and mild-to-moderate cognitive impairment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vericiguat | Drug | Tablet - 2.5 mg, 5 mg, 10 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin Ezekowitz, MBBCh, MSc | Contact | 780-492-0712 | jae2@ualberta.ca | |
| Amanda Perreault, MSc | Contact | 780-492-5484 | aperreau@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Justin Ezekowitz, MBBCh, MSc | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | Canada | ||
| University of Alberta |
There are no plans to share IPD at this time.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| C000603960 | vericiguat |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 26 weeks |
| Clinical events - Death | (all cause) | 26 weeks |
| Clinical events - Hospitalizations | (all cause) | 26 weeks |
| Clinical events - Emergency Department Visits | (all cause) | 26 weeks |
| Clinical events - Stroke | 26 weeks |
| Clinical events - Other | 26 weeks |
| Recruiting |
| Edmonton |
| Alberta |
| Canada |
| University of Ottawa | Recruiting | Ottawa | Ontario | Canada |
| McGill University Health Center | Not yet recruiting | Montreal | Quebec | Canada |
| D001523 |
| Mental Disorders |