To evaluate the effect of Ayurvedic Drug Hridya Mahakashaya in Patients with Heart failure with reduced Ejection fraction(AYURVEDA-HF)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,248
- 试验地点
- 1
- 主要终点
- To determine whether Drug Hridya Mahakashay is superior to placebo, when added to standard of care, in reducing the incidence of CV death or a HF event.
研究概览
简要总结
The title of this research trial is " To evaluate the effect of Ayurvedic Drug Hridya Mahakashaya in Patients with Heart failure with reduced Ejection fraction(AYURVEDA-HF)". For this trial diagnosed cases of heart failure will be registered from OPD of Cardiology, Sir Sundar Lal Hospital, BHU, Varanasi after taking consent. The study is a double blind, parallel group, event driven single center randomized to patients with chronic heart failure, evaluating the effect of drug Hridya Mahakashay given in powder form 3 to 5 grams thrice daily, in addition to standard allopathic care, compared with standard allopathic heart failure medications , on the primary composite outcome of a worsening heart failure events (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death. Patient will be also examined by Ayurvedic Nadi Pariksha ( pulse examination) and also by Nadi Tarangini machine .
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Men and women aged 18 years or older with a diagnosis of heart failure for at least 2 months are eligible if they are fulfilling the criteria described in New York Heart Association functional class II or above, have a left ventricular ejection fraction documented to be ≤ 40% within the last 12 months.
- •Patients must have a Nâ€terminal pro Bâ€type natriuretic peptide concentration ≥ 600 pg/mL OR if hospitalised for heart failure within the previous 12 months, ≥ 400 pg/mL.
- •Patients with atrial fibrillation OR atrial flutter must have a level ≥ 900 pg/mL, irrespective of history of heart failure hospitalization.
- •4.Provide written informed consent for participation in the study.
排除标准
- •Recent Acute coronary syndrome within 3 months.
- •Recent coronary revascularization within 3 months.
- •Implantation of a CRT device within 12 weeks prior to enrolment or intent to implant a CRT device
- •Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
- •HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or uncorrected primary valvular disease
- •Symptomatic bradycardia or second or thirdâ€degree heart block without a pacemaker
- •Any condition outside the cardiovascular and renal disease area, such as but not limited to malignancy, with a life expectancy of & lt; 2 years based on investigator's clinical judgement
- •Active malignancy requiring treatment at the time of Visit 1(with the exception of successfully treated basal cell or treated squamous cell carcinoma)
- •Hepatic impairment (aspartate transaminase or alanine transaminase > 3 × the ULN, or total bilirubin > 2 × ULN at time of enrolment).
- •An isolated increase in bilirubin in patients with known Gilbert's syndrome is not a reason for exclusion
- •Known bloodâ€borne diseases representing a shipping/transportation biohazard
- •Women of childâ€bearing potential (i.e. those who are not chemically or surgically sterilized or who are not postâ€menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgement of the investigator, from the time of signing the informed consent throughout the study and 4 weeks thereafter, or women who have a positive pregnancy test at enrolment or randomization, or women who are breastâ€feeding
- •Participation in another clinical study with an IP during the last month prior to enrolment
- •Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or followâ€up, or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
结局指标
主要结局
To determine whether Drug Hridya Mahakashay is superior to placebo, when added to standard of care, in reducing the incidence of CV death or a HF event.
时间窗: 24 months
次要结局
- To compare the effect of Drug Hridya Mahakashay vs. placebo on total number of recurrent HF hospitalizations and CV death.(24 months)