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Sacubitril/Valsartan (SAC/VAL) is a new treatment of congestive heart failure (CHF) recently indicated as class I, level of evidence B in the recent European Society of Cardiology (ESC) guidelines 2016 of CHF. PARADIGM-HF trial demonstrated a significant improvement of morbidity and mortality with SAC/VAL in comparison to enalapril. So far, no data available about the effect of usage of SAC/VAL post-acute myocardial infarction (AMI) except in animal experimental models.
The purpose of the research is evaluation of the effects of SAC/VAL in post-AMI in comparison to the traditional Angiotensin Converting Enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in a real-life clinical trial in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.
Background and study rationale:
Sacubitril/Valsartan (SAC/VAL) is now approved by the U.S. Food and Drug Administration (FDA) for heart failure with reduced ejection fraction (HFrEF) and also, recently indicated as class I indication, level of evidence B in the European Society of Cardiology (ESC) guidelines 2016 on congestive heart failure (CHF).(1) PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SAC/VAL In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalization for CHF by 20% with a 16% reduction in all-cause mortality.(2) So far, no available data about the effect of usage of SAC/VAL in post-AMI except in animal experimental models that proved efficacy of SAC/VAL in preventing AMI-induced LV dysfunction compared with SAC/VAL, also significantly attenuated LV scar size following AMI compared with placebo .(3)
Aim of the work:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacubitril/Valsartan | Experimental | In successfully revascularized post-AMI patients with LVEF ≤40% Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months. |
|
| Valsartan | Active Comparator | In successfully revascularized post-AMI patients with LVEF ≤40% Valsartan with an initial dose of 40 mg PO BID, with subsequent titrations to target maintenance dose of 160 mg BID as tolerated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacubitril / Valsartan Oral Tablet [Entresto] | Drug | Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| One week major adverse cerebrovascular and cardiovascular events (MACCE) | Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 1 week after AMI | 1 week after AMI |
| Twenty four weeks major adverse cerebrovascular and cardiovascular events (MACCE) | Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 24 weeks after AMI | 24 weeks after AMI |
| Change in the ejection fraction during hospital stay, 3 months and 6 months after AMI. | Change in the ejection fraction assessed by transthoracic echocardiography assessment (TTE) during hospital stay, 3 months and 6 months after AMI. | In hospital, 3 months and 6 months after AMI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherif S Elbeltagui, MD | Assisstant Professor of Cardiology, University of Alexandria, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andalusia Hospitals | Alexandria | 21524 | Egypt |
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| ID | Term |
|---|---|
| C000717211 | sacubitril |
| D000068756 | Valsartan |
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |