Recruiting
Phase 2

Observational Study

Sponsor:

University of Alberta

Code:

NCT06601465

Conditions

Heart Failure

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vericiguat

Study Details

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.

Conditions

Heart Failure

Cognitive Impairment

Study ID

NCT06601465

Start date

Jun 3, 2025

Status verified date

Aug, 2026

Completion date

Jul 16, 2028

Anticipated

Primary completion date

Jul 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Standard of Care

Conventional management of heart failure and mild-to-moderate cognitive impairment.

Interventions

Vericiguat

Tablet - 2.5 mg, 5 mg, 10 mg

Primary outcome measure

  • Change in the lateral ventricular volumes. [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Justin Ezekowitz, MBBCh, MSc

780-492-0712jae2@ualberta.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada

University of Alberta

Recruiting

Edmonton, Alberta, Canada

University of Ottawa

Recruiting

Ottawa, Ontario, Canada

More Information

Sponsor

University of Alberta

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Heart Failure
  • Cognitive Impairment
  • Vericiguat

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-08-25.