The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— RSVP-AMI  

Official title:

The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction: The RSVP-AMI Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893435
• Other study ID #: YIG01201902
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: The Young Investigator Group of Cardiovascular Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Sacubitril / Valsartan Oral Tablet [Entresto]
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.

Locations

Country	Name	City	State
Egypt	Andalusia Hospitals	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
The Young Investigator Group of Cardiovascular Research

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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