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Completed

NCT Number: NCT03893435

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andalusia Hospitals

Alexandria, 21524, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ARNI

Primary outcomes

  1. One week major adverse cerebrovascular and cardiovascular events (MACCE)

    Time frame: 1 week after AMI

    Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 1 week after AMI

  2. Twenty four weeks major adverse cerebrovascular and cardiovascular events (MACCE)

    Time frame: 24 weeks after AMI

    Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 24 weeks after AMI

  3. Change in the ejection fraction during hospital stay, 3 months and 6 months after AMI.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Young Investigator Group of Cardiovascular Research

Network

Registry information

Official study title

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

Acronym: RSVP-AMI

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2019
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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