Clinical trial NCT06601465: COgnitioN With VERiciGuat Evaluation in Heart Failure
Official title: CONVERGE-HF: COgnitioN With VERiciGuat Evaluation in Heart Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Heart Failure
Cognitive Impairment
Keywords: Heart Failure
Cognitive Impairment
Vericiguat
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Ottawa Heart Institute Research Corporation
name: Heart and Stroke Foundation of Canada
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 criteria: 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: renal failure \[a glomerular filtration rate \&lt;30 mL/min)\], 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.

Primary outcomes:
measure: Change in the lateral ventricular volumes.
timeFrame: 26 weeks
Secondary outcomes:
measure: Blood Biomarkers (a)
timeFrame: 26 weeks
measure: Blood Biomarkers (b)
timeFrame: 26 weeks
measure: Imaging Biomarkers (Cardiac)
timeFrame: 26 weeks
measure: Imaging Biomarkers (Brain)
timeFrame: 26 weeks
measure: Clinical and patient-reported outcomes (MoCA)
timeFrame: 26 weeks
measure: Clinical and patient-reported outcomes (KCCQ-12)
timeFrame: 26 weeks
measure: Clinical and patient-reported outcomes (6MWT)
timeFrame: 26 weeks
measure: Clinical and patient-reported outcomes (RBANS)
timeFrame: 26 weeks
measure: Clinical events - Death
timeFrame: 26 weeks
measure: Clinical events - Hospitalizations
timeFrame: 26 weeks
measure: Clinical events - Emergency Department Visits
timeFrame: 26 weeks
measure: Clinical events - Stroke
timeFrame: 26 weeks
measure: Clinical events - Other
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: University of Alberta
name: Justin Ezekowitz, MBBCh, MSc
role: PRINCIPAL_INVESTIGATOR
References: