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Trial record 7 of 204 for:    epidiolex

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03634189
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
David Rodriguez, Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

Brief Summary:
Cannabidiol in heart failure

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Cannabidiol Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Single Center, Open-label Study of Cannabidiol in Patients With Heart Failure in AHA/ACC Stages A-C
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. Number of participants with treatment-related serious adverse events and events of interest as assessed by MedDRA v5.1 [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634189


Contacts
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Contact: Guillermo Torre-Amione, MD, PhD +52-81-8888-0500 guillermo.torre@itesm.mx

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

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Responsible Party: David Rodriguez, Clinical Research Coordinator, Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
ClinicalTrials.gov Identifier: NCT03634189     History of Changes
Other Study ID Numbers: CAPITAL-AC
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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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
Keywords provided by David Rodriguez, Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud:
Cannabidiol
Heart Failure
AHA/ACC stage A-C
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Epidiolex
Anticonvulsants