Cannabidiol in Patients With Heart Failure Failure in AHA/ACC Stages A-C

Study Overview
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Brief Summary
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Cannabidiol in heart failure

Official Title
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Phase I, Single Center, Open-label Study of Cannabidiol in Patients With Heart Failure in AHA/ACC Stages A-C

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Cannabidiol


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Men and women (women not pregnant neither in lactation period) between 30 to 75 years-old Patients with stage A-C of the American College of Cardiology/American Heart Association classification Patients with GDMT and clinical stability within four weeks Diagnosis of ischemic or non-ischemic dilated cardiomyopathy Participants should sign an informed consent form (ICF) form personally Exclusion criteria Severe primary valvular cardiomyopathy or valvular prosthesis (mechanical or bio-valve) History of heart transplant surgery, cardiomyoplasty, left ventricular reduction surgery, valvuloplasty, implantation of a ventricle assist device and surgical cardiac congenital defect correction Implantable cardioverter defibrillator within the last three months Acute coronary syndromes that required pharmacological or mechanical reperfusion or medical treatment, within 30 days before selection Percutaneous coronary intervention within 30 days prior to selection Women who are pregnant, or of childbearing potential and are not practicing an effective means of birth control Untreated thyroid disease Hepatorenal syndrome History of seizures Hemoglobin: < 8.5 gm/dL WBC count lower than 3000/mm3 Platelets: <100,000/mm AST or ALT >2.5 × upper limit of normal (ULN) unless related to primary disease Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer) Active cancer of any etiology History of psychiatric disorder (depression or PHQ-9 ≥ 10 points , bipolar syndrome, schizophrenia) or suicide attempt. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications Fertile female participants not applying any approved duel anti-contraceptive method Inability to comply/assist with study and follow-up procedures Patients in cardiovascular rehabilitation programs Any person who is not able to give adequate ICF Elimination criteria Progression of heart failure stage according to the American College of Cardiology/American Heart Association classification, since the initiation of the study. ALT or AST >3x normal values with a total bilirubin ≥ 2x normal value. Any degree of depression at any stage of the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HF- ACC/AHA stage A-C + CBD<br>Patients with HF stages A-C + Cannabidiol | Drug: Cannabidiol<br>* Patients with ACC/AHA stage A-C will receive 5 mg/kg to a maximum tolerated dose of 25 mg/kg PO BID of Cannabidiol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related serious adverse events and events of interest as assessed by MedDRA v5.1 | We will assess the safety of CBD in patients with HF ACC/AHA stages A-C based on the incidence of events of interest and serious adverse events. This assessment will be performed at each on-site visit. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Cannabidiol, AHA/ACC stage A-C