Left-side Heart Failure
Conditions
Interventions
105 outpatients will be randomized 1:1 to either oral cannabidiol or placebo. Arm Cannabidiol: Oral cannabidiol extract (CBD 100 Isolate
VerdeMed Care®). Patients will receive 25mg once a day to a maximum dose of 100mg twice a day, per oral use for 4 months. Placebo Comparator: Oral placebo extract. Placebo matching cannabidiol for 4
Sponsors
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
VerdeMed Brasil Participações
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age: 18 years to 70 years; Established documented diagnosis of Heart Failure (HF) With Reduced Left Ventricle Ejection Fraction (LVEF less than 40%), which has been present for at least 12 months; Persisted HF symptoms and low quality of life defined as: New York Heart Association (NYHA) functional class III-IV or NYHA functional class II and at least one criteria: Minnesota Living with Heart Failure Questionnaire (MLHFQ) score greater than or equal to 50 points; 6 minute walk test less than 325 metres; Elevated BNP levels; Patients should receive standard of care for heart failure with reduced ejection fraction (HFrEF) and be treated according to locally recognized guidelines
Exclusion criteria
Exclusion criteria: Expected surgical or percutaneous treatment for HF (coronary revascularization, valve procedure, implantation of resynchronization therapy or implantable cardioverter-defibrillator, heart transplantation, left ventricular assist device) within the next 6 months of randomization; Current acute decompensated HF or hospitalization due to decompensated HF within 30 days prior to enrolment; Acute myocarditis within 6 month prior to enrolment; HF due to restrictive cardiomyopathy, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease; HF etiology that presents potential reversibility of the disease according to the investigators' judgment; Myocardial infarction or unstable angina within 6 month prior to enrolment; Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 6 month prior to enrolment or planned to undergo any of these operations after randomization; Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization; Implantation of a Cardiac resynchronization therapy (CRT) or implantable cardioverter-defibrillator (ICD) within 6 month prior to enrolment or intent to implant a CRT or ICD device; Patient in a cardiovascular rehabilitation program; Stroke or transient ischemic attack within 12 month prior to enrolment; Severe (eGFR less tha 20 mL/min/1.73 m2 by CKD-EPI), renal disease at the time of randomization; Any condition outside the cardiovascular and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator’s clinical judgment; Limiting or disabling neurological or musculoskeletal conditions; Current Sars-Cov2 infection or hospital discharge for COVID-19 within the last 30 days; Post-COVID-19 syndrome defined by persistence or onset of symptoms or sequelae (eg, fatigue, chest pain, dyspnea, decreased quality of life, muscle and joint pain, anxiety, sleep disturbances, palpitations or thromboembolism) after 4 weeks of SARS-Cov2 infection, not attributed to other causes; Active malignancy; Women who have a positive pregnancy test at enrolment or randomization, or women who are breast-feeding; Use of Illicit drugs within 24 month prior to enrolment; Severe Hepatic impairment; Human immunodeficiency virus (HIV) patients; Seizures or use of anticonvulsants drugs; Schizophrenia, bipolar disorder or attempted suicide; Glaucoma; Hypersensitivity to any cannabinoid substance or contained in cannabidiol extract; Any systemic disease evaluated by the investigators that compromises the result or poses a risk to the trial; Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up, or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study; Participation in another clinical research protocol; Refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Determine that the use of Cannabidiol is superior to placebo in improving quality of life defined as a decrease of more than 10% from the baseline Minnesota Living with Heart Failure Questionnaire total score after 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assess Safety and tolerability of cannabidiol in patients with chronic heart failure with reduced ejection fraction in 4 months;2. Time to the first occurrence of cardiovascular death or hospitalization for heart failure;3. Determine the composite endpoint of cardiovascular death and hospitalization due to heart failure in 4 months;4. Evaluate all-cause mortality in 4 months;5. Evaluate the effects of cannabidiol on general symptoms, depression, anxiety and dyspnea;6. Evaluate the effects of cannabidiol on functional capacity measured by the 6-minute walk test and ergospirometric parameters | — |
Countries
Brazil
Contacts
Public ContactBruno Biselli
Instituto do Coração (INCOR) - Faculdade de Medicina da Universidade de São Paulo (FMUSP)
Outcome results
None listed