Health TrialsbyHealthPanel

COgnitioN With VERiciGuat Evaluation in Heart Failure

ConditionsHeart FailureCognitive Impairment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vericiguat

    Drug

    Tablet - 2.5 mg, 5 mg, 10 mg

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: VericiguatExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
26 weeks

Secondary outcomes

1

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
2

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
3

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
4

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.

Time frame
26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Ottawa Heart Institute Research Corporation

Collaborator

Heart and Stroke Foundation of Canada

Collaborator

Source ClinicalTrials.gov
Apply now