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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cannabidiol
Sponsored by
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cannabidiol, Heart Failure, AHA/ACC stage A-C

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HF- ACC/AHA stage A-C + CBD

    Arm Description

    Patients with HF stages A-C + Cannabidiol

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 13, 2018
    Last Updated
    August 4, 2020
    Sponsor
    Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03634189
    Brief Title
    Cannabidiol in Patients With Heart Failure Failure in AHA/ACC Stages A-C
    Acronym
    CAPITAL-AC
    Official Title
    Phase I, Single Center, Open-label Study of Cannabidiol in Patients With Heart Failure in AHA/ACC Stages A-C
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    September 1, 2021 (Anticipated)
    Study Completion Date
    December 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Cannabidiol in heart failure

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Cannabidiol, Heart Failure, AHA/ACC stage A-C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HF- ACC/AHA stage A-C + CBD
    Arm Type
    Experimental
    Arm Description
    Patients with HF stages A-C + Cannabidiol
    Intervention Type
    Drug
    Intervention Name(s)
    Cannabidiol
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Number of participants with treatment-related serious adverse events and events of interest as assessed by MedDRA v5.1
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guillermo Torre-Amione, MD, PhD
    Phone
    +52-81-8888-0500
    Email
    guillermo.torre@itesm.mx

    12. IPD Sharing Statement

    Learn more about this trial

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

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