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NCT Number: NCT06601465

COgnitioN With VERiciGuat Evaluation in Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Heart Diseases Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vericiguat

Drug

Tablet - 2.5 mg, 5 mg, 10 mg

Other names: Verquvo

Primary outcomes

  1. Change in the lateral ventricular volumes.

    Time frame: 26 weeks

    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.

Secondary outcomes

  1. Blood Biomarkers (a)

    Time frame: 26 weeks

    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.

  2. Blood Biomarkers (b)

    Time frame: 26 weeks

    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.

  3. Imaging Biomarkers (Cardiac)

    Time frame: 26 weeks

    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.

  4. Imaging Biomarkers (Brain)

    Time frame: 26 weeks

    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.

  5. Clinical and patient-reported outcomes (MoCA)

    Time frame: 26 weeks

    To compare the change of MoCA scores in 26 weeks between groups who were treated with vericiguat versus standard of care.

  6. Clinical and patient-reported outcomes (KCCQ-12)

    Time frame: 26 weeks

    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.

  7. Clinical and patient-reported outcomes (6MWT)

    Time frame: 26 weeks

    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.

  8. Clinical and patient-reported outcomes (RBANS)

    Time frame: 26 weeks

    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.

  9. Clinical events - Death

    Time frame: 26 weeks

    (all cause)

  10. Clinical events - Hospitalizations

    Time frame: 26 weeks

    (all cause)

  11. Clinical events - Emergency Department Visits

    Time frame: 26 weeks

    (all cause)

  12. Clinical events - Stroke

    Time frame: 26 weeks

  13. Clinical events - Other

    Time frame: 26 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Perreault, MSc

CONTACT

[email protected]

780-492-5484

Justin Ezekowitz, MBBCh, MSc

CONTACT

[email protected]

780-492-0712

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Heart and Stroke Foundation of Canada
  • Ottawa Heart Institute Research Corporation

Registry information

Official study title

CONVERGE-HF: COgnitioN With VERiciGuat Evaluation in Heart Failure

Acronym: CONVERGE-HF

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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