Cannabidiol in Patients With Heart Failure Failure in AHA/ACC Stages A-C (CAPITAL-AC)

Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

Status and phase

Unknown

Phase 1

Conditions

Heart Failure

Treatments

Drug: Cannabidiol

Study type

Interventional

Funder types

Other

Identifiers

NCT03634189

CAPITAL-AC

Details and patient eligibility

About

Cannabidiol in heart failure

Enrollment

20 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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