Effect of Ayurvedic herbal medicine in Heart Failure

Phase 3

• Conditions: Health Condition 1: I420- Dilated cardiomyopathy

• Registration Number: CTRI/2022/09/045856
• Lead Sponsor: Institute of Eminence IoE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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 third�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 blood�borne diseases representing a shipping/transportation biohazard

11. Women of child�bearing potential (i.e. those who are not chemically or surgically sterilized or who are not post�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 breast�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 follow�up, or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified