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Recruiting NCT06601465

COgnitioN With VERiciGuat Evaluation in Heart Failure

Phase II Interventional Heart Failure Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vericiguat.
Who it may be relevant to
Registry conditions: Heart Failure, Cognitive Impairment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CONVERGE-HF: COgnitioN With VERiciGuat Evaluation in Heart Failure

Overview

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.

Interventions

  • Drug Vericiguat
    Tablet - 2.5 mg, 5 mg, 10 mg

Primary outcome measures

  • Change in the lateral ventricular volumes. [Time frame: 26 weeks]
Secondary outcome measures (12)
  • Blood Biomarkers (a) [Time frame: 26 weeks]
  • Blood Biomarkers (b) [Time frame: 26 weeks]
  • Imaging Biomarkers (Cardiac) [Time frame: 26 weeks]
  • Imaging Biomarkers (Brain) [Time frame: 26 weeks]
  • Clinical and patient-reported outcomes (MoCA) [Time frame: 26 weeks]
  • Clinical and patient-reported outcomes (KCCQ-12) [Time frame: 26 weeks]
  • Clinical and patient-reported outcomes (6MWT) [Time frame: 26 weeks]
  • Clinical and patient-reported outcomes (RBANS) [Time frame: 26 weeks]
  • Clinical events - Death [Time frame: 26 weeks]
  • Clinical events - Hospitalizations [Time frame: 26 weeks]
  • Clinical events - Emergency Department Visits [Time frame: 26 weeks]
  • Clinical events - Stroke [Time frame: 26 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 4 centers
  • University of Calgary — Calgary
  • University of Alberta — Edmonton
  • University of Ottawa — Ottawa
  • McGill University Health Center — Montreal

Identifiers

NCT: NCT06601465 · CONVERGE-HF-2023-6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗