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

Heart Failure Clinical Trial

— CAPITAL-AC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03634189
• Other study ID #: CAPITAL-AC
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2020
• Source: Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
• Contact: Guillermo Torre-Amione, MD, PhD
• Phone: +52-81-8888-0500
• Email: guillermo.torre[@]itesm.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cannabidiol in heart failure

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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