Status:
UNKNOWN
Early Treatment of ARNI on Myocardial Remodeling and Progress
Lead Sponsor:
RenJi Hospital
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Myocardial remodeling following myocardial infarction (MI) is an important prognostic factor for heart function and adverse cardiovascular events, especially are intimately linked with heart failure. ...
Detailed Description
Myocardial remodeling following myocardial infarction (MI) is an important prognostic factor for heart function and adverse cardiovascular events. The angiotensin receptor neprilysin inhibitor (ARNI) ...
Eligibility Criteria
Inclusion
- Acute myocardial infarction (AMI) within 1 months prior to recruitment;
- Aged 18 years or over and under 80 years;
- Randomized patients will have been hemodynamically stable, SBP ≥100mmHg, no symptomatic hypotension;
- NYHA Class Ⅱ-Ⅳ, HFrEF or HFpEF;
- Elevated NT-proBNP or BNP at the time of screening;
- Peak VO2/kg\<16 ml/kg/min by CPET
Exclusion
- Inability to complete a CPET;
- Symptomatic hypotension and/or systolic blood pressure \<100mmHg;
- eGFR \< 30 mL/min/1.73m2 and/or serum potassium \>5.2mmol/L;
- History of hypersensitivity or allergy to ACE-inhibitors/ARB
- History of angioedema;
- Pregnancy, planning pregnancy, or breast feeding;
- Life-threatening diseases with limited life expectancy \<1 year
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04342351
Start Date
May 1 2020
End Date
December 30 2021
Last Update
April 14 2020
Active Locations (1)
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1
RenJi Hospital, Shanghai JiaoTong University, School of Medicine
Shanghai, Shanghai Municipality, China, 200127