RBR-9z6dw6b尚未招募2 期
Cannabidiol in Patients with Chronic Heart Failure: a prospective, randomized, double-blind, controlled trial
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo0 个研究点开始时间: 2022年2月21日最近更新:
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 70Y（—）
入选标准
- •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
排除标准
- •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
研究者
相似试验
Unknown
1 期
Cannabidiol in Patients With Heart Failure Failure in AHA/ACC Stages A-CHeart FailureNCT03634189Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud20
进行中（未招募）
1 期
Sildenafil in Chronic Heart Failure; An investigator initiated multi-national clinical research study.MedDRA version: 18.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849Chronic Heart FailureEUCTR2011-002829-21-ITStavanger Helseforskning AS120
已完成
不适用
patientes with CONgestive heart failure benefit for long-TErm treatment effects with New Treatment using azosemide compared with furosemide derived from Existing retrospective study DataPatients with moderate congestive heart failureJPRN-UMIN000021994Dokkyo Medical University100
尚未招募
不适用
Multi-center, randomized, double-blind, placebo parallel controlled evaluation Clinical Study on the efficacy and safety of Kuxin Pingni Granules in Treating Chronic Heart Failurechronic heart failureITMCTR2200005839Jiangsu Province Hospital of Integration of Chinese and Western Medicine
已完成
不适用
eural Cardiac Therapy for Heart Failure Studycardiac remodeling10019280Heart failureNL-OMON46859Boston Scientific20