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

NCT03634189 | Unknown Phase 1 DMC

• 1 other identifier: CAPITAL-AC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cannabidiol in heart failure

Conditions

Heart Failure

Keywords

Cannabidiol; Heart Failure; AHA/ACC stage A-C

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HF- ACC/AHA stage A-C + CBD

EXPERIMENTAL

Patients with HF stages A-C + Cannabidiol

Drug: Cannabidiol

Interventions

Cannabidiol 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

HF- ACC/AHA stage A-C + CBD

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Heart Failure

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Guillermo Torre-Amione, MD, PhD

CONTACT

+52-81-8888-0500; guillermo.torre@itesm.mx

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 16, 2018
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 5, 2020

Record last verified: 2020-08