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Clinical Trials/CTRI/2022/09/045856
CTRI/2022/09/045856Not yet recruitingPhase 3

To evaluate the effect of Ayurvedic Drug Hridya Mahakashaya in Patients with Heart failure with reduced Ejection fraction(AYURVEDA-HF)

Institute of Eminence IoE0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility 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 ââ?°Â¤ 40% within the last 12 months.
  • •2. Patients must have a Nââ?¬?terminal pro Bââ?¬?type natriuretic peptide concentration ââ?°Â¥ 600 pg/mL
  • •OR if hospitalised for heart failure within the previous 12 months, ââ?°Â¥ 400 pg/mL.
  • •3. Patients with atrial fibrillation
  • •OR atrial flutter must have a level ââ?°Â¥ 900 pg/mL, irrespective of history of heart failure hospitalization.
  • •4.Provide written informed consent for participation in the study.

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
  • •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
  • •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.

Investigators

Sponsor
Institute of Eminence IoE

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