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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Cannabidiol in heart failure

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
• Treatments: Cannabidiol

Criteria

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