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
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
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
NCT ID
NCT03634189
First Posted
August 13, 2018
Last Updated
August 4, 2020
Sponsor
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
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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