Clinical trial NCT03634189: Cannabidiol in Patients With Heart Failure Failure in AHA/ACC Stages A-C
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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Heart Failure
Keywords: Cannabidiol
Heart Failure
AHA/ACC stage A-C
Lead sponsor: Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cannabidiol in heart failure


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

Primary outcomes:
measure: Number of participants with treatment-related serious adverse events and events of interest as assessed by MedDRA v5.1
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: