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

NCT ID: NCT03634189

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-12-01

Brief Summary

Cannabidiol in heart failure

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HF- ACC/AHA stage A-C + CBD

Patients with HF stages A-C + Cannabidiol

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

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

Interventions

Cannabidiol

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

David Rodriguez

Clinical Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Guillermo Torre-Amione, MD, PhD

Role: CONTACT

guillermo.torre@itesm.mx

+52-81-8888-0500

Other Identifiers

CAPITAL-AC

Identifier Type: -

Identifier Source: org_study_id