Health Condition 1: I420- Dilated cardiomyopathy
Conditions
Interventions
None listed
Sponsors
Institute of Eminence IoE
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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. 2. Patients must have a N�terminal pro B�type natriuretic peptide concentration � 600 pg/mL OR if hospitalised for heart failure within the previous 12 months, � 400 pg/mL. 3. 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.
Exclusion criteria
Exclusion criteria: 1. Recent Acute coronary syndrome within 3 months. 2. Recent coronary revascularization within 3 months. 3. Implantation of a CRT device within 12 weeks prior to enrolment or intent to implant a CRT device 4. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization 5. HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or uncorrected primary valvular disease 6. Symptomatic bradycardia or second or thirdââ?¬?degree heart block without a pacemaker 7. 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 8. Active malignancy requiring treatment at the time of Visit 1(with the exception of successfully treated basal cell or treated squamous cell carcinoma) 9. Hepatic impairment (aspartate transaminase or alanine transaminase > 3 Ã?â?? the ULN, or total bilirubin > 2 Ã?â?? ULN at time of enrolment). An isolated increase in bilirubin in patients with known Gilbert's syndrome is not a reason for exclusion 10. Known bloodââ?¬?borne diseases representing a shipping/transportation biohazard 11. Women of childââ?¬?bearing potential (i.e. those who are not chemically or surgically sterilized or who are not postââ?¬?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 breastââ?¬?feeding 12. Participation in another clinical study with an IP during the last month prior to enrolment 13. Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or followââ?¬?up, or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of Drug Hridya Mahakashay vs. placebo on total number of recurrent HF hospitalizations and CV death.Timepoint: 24 months | — |
Countries
India
Contacts
Public ContactDr Suyash Tripathi
Banaras Hindu University
Outcome results
None listed