Acute Myocardial Infarction
Conditions
Brief summary
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.
Detailed description
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: * This study aims to investigate the effects of SAC/VAL in post-AMI through using it instead of conventional Angiotensin Converting enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in treatment of post-AMI patients with reduced left ventricular (LV) systolic function. * Design: Randomized open label interventional clinical trial.
Interventions
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.
Sponsors
The Young Investigator Group of Cardiovascular Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post-AMI patients who underwent successful PPCI and LVEF ≤40%.
Exclusion criteria
* Post-AMI patients who underwent successful PPCI and LVEF \>40%. * History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs. * Symptomatic hypotension and/or an SBP \< 100 mmHg. * Estimated GFR \< 30 mL/min/1.73m2 as measured by the simplified MDRD formula or serum potassium \> 5.2 mmol/L.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One week major adverse cerebrovascular and cardiovascular events (MACCE) | 1 week after AMI | Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 1 week after AMI |
| Twenty four weeks major adverse cerebrovascular and cardiovascular events (MACCE) | 24 weeks after AMI | Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 24 weeks after AMI |
| Change in the ejection fraction during hospital stay, 3 months and 6 months after AMI. | In hospital, 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. |
Countries
Egypt
Outcome results
None listed