COgnitioN With VERiciGuat Evaluation in Heart Failure (CONVERGE-HF)

CONVERGE-HF: 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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cognitive Impairment
• Intervention / Treatment: Drug: Vericiguat

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Justin Ezekowitz, MBBCh, MSc; Phone Number: 780-492-0712; Email: jae2@ualberta.ca
• Study Contact Backup: Name: Amanda Perreault, MSc; Phone Number: 780-492-5484; Email: aperreau@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • University of Calgary
    • Edmonton, Alberta, Canada
      • Recruiting
      • University of Alberta
  • Ontario
    • Ottawa, Ontario, Canada
      • Recruiting
      • University of Ottawa
  • Quebec
    • Montreal, Quebec, Canada
      • Not yet recruiting
      • McGill University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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: 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vericiguat; 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.	Drug: Vericiguat; Tablet - 2.5 mg, 5 mg, 10 mg; Other Names: Verquvo
No Intervention: Standard of Care; Conventional management of heart failure and mild-to-moderate cognitive impairment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Ottawa Heart Institute Research Corporation; Heart and Stroke Foundation of Canada
• Investigators: Principal Investigator: Justin Ezekowitz, MBBCh, MSc, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Cognitive Impairment; Vericiguat
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Mental Disorders; Heart Diseases; Neurocognitive Disorders; Cognition Disorders; Heart Failure; Cognitive Dysfunction
• Other Study ID Numbers: CONVERGE-HF-2023-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share IPD at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes