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

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

Cannabidiol in heart failure

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Cannabidiol

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guillermo Torre-Amione, MD, PhD; Phone Number: +52-81-8888-0500; Email: guillermo.torre@itesm.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HF- ACC/AHA stage A-C + CBD; Patients with HF stages A-C + Cannabidiol	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (ACTUAL): August 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Heart Failure; Cannabidiol; AHA/ACC stage A-C
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: CAPITAL-AC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No