Clinical trial NCT03893435: The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction
Official title: The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction: The RSVP-AMI Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: The Young Investigator Group of Cardiovascular Research
Sponsor class: NETWORK
First posted: 2019-03-28
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: One week major adverse cerebrovascular and cardiovascular events (MACCE)
timeFrame: 1 week after AMI
measure: Twenty four weeks major adverse cerebrovascular and cardiovascular events (MACCE)
timeFrame: 24 weeks after AMI
measure: Change in the ejection fraction during hospital stay, 3 months and 6 months after AMI.
timeFrame: In hospital, 3 months and 6 months after AMI
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Andalusia Hospitals
Study officials:
affiliation: Assisstant Professor of Cardiology, University of Alexandria, Egypt
name: Sherif S Elbeltagui, MD
role: STUDY_DIRECTOR
References: