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Open label randomized control trial "Comparision of valsartan plus sacubitril vs ramipril in acute myocardial infarction with HFmEF and HFrEF"

"Sacubitril plus Valsartan Vs Ramipril in acute myocardial infarction with heart failure with reduced and mid range ejection fraction :A Randomized control trial" - CARAMI

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027406
Enrollment
160
Registered
2020-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I219- Acute myocardial infarction, unspecified

Interventions

Intervention1: ARNI(ANGIOTENSION RECEPTOR AND NEPROLYSIN INHIBITOR): 50mg to 200mg Twice a day Orally 3 months Intervention2: Angiotensin receptor neprolysin inhibitor: angiotensin receptor blocker b

Sponsors

aiims hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosis of spontaneous AMI based on the universal MI definition (2018) -with randomization to occur between 12 hours and 7 days after index MI presentation. 2.EF would calculate using ECHO after index MI presentation and prior to randomization 3.Systolic blood pressure at enrolment would be minimum >=100mmHg irrespective of ongoing beta blocker or ACEI

Exclusion criteria

Exclusion criteria: 1. Cardiogenic shock 2. Coronary artery bypass graft (CABG) 3. Right ventricular MI 4. A known history of angioedema 5. Stroke /transient ischemic attack 6. Bilateral renal artery stenosis 7. Obstructive cardiomyopathy 8. Serum creatinine >2.2 mg/dl 9. Total bilirubin > 3.0 mg/dL) 10. Cirrhosis 11. Previous use of ARNI 12. History of malignancy

Design outcomes

Primary

MeasureTime frame
Improvement in LVEF% (increase in LVEF by 10% from baseline) measured by Simpsonâ??s ruleTimepoint: 15 months

Secondary

MeasureTime frame
Monitoring change in NYHA functional class Monitoring NT pro BNP level in blood Monitoring serum creatinine and potassium level in blood Timepoint: 15 months

Countries

India

Contacts

Public ContactDr Rama Chandra Barik

AIIMS BBSR

ramachandra@gmail.com9491634156

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026