Heart Failure
Conditions
Keywords
Cannabidiol, Heart Failure, AHA/ACC stage A-C
Brief summary
Cannabidiol in heart failure
Interventions
DRUGCannabidiol
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
Sponsors
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related serious adverse events and events of interest as assessed by MedDRA v5.1 | 6 months | 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. |
Contacts
Primary ContactGuillermo Torre-Amione, MD, PhD
Outcome results
None listed