Clinical trial NCT04342351: Early Treatment of ARNI on Myocardial Remodeling and Progress
Official title: Early Treatment of ARNI on Myocardial Remodeling and Progress in Patients With Post-AMI (EARLYmyo-CRPⅠ)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. MI often causes deleterious changes in ventricular size, shape, and function. This adverse remodeling and progress is mediated by neurohormonal and hemodynamic alterations. The angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan was shown to be superior to an ACE inhibitor in patients with heart failure with reduced ejection fraction (HF-REF), reduce the risk of both death (from cardiovascular and all-causes) and heart failure hospitalization, may be a new approach to the treatment of heart failure. However, the impact of early treatment of ARNI on myocardial remodeling and progress, and aerobic exercise capacity in patients with prior MI has yet to be assessed. The aim of this study is to evaluate the efficacy and the safety of early treatment of ARNI on myocardial remodeling and progress, and aerobic exercise capacity in patients following MI.

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) sacubitril/valsartan was shown to reduce the risk of both death (from cardiovascular and all-causes) and heart failure hospitalization. However, whether early treatment of ARNI following post-MI could alter myocardial remodeling or aerobic exercise capacity has yet to be assessed. The patients with MI within one month were enrolled in the treatment of ARNI group or ACEI group. The study proposes to perform serial Cardiopulmonary Exercise Tests (CPET) to prospectively measure changes in aerobic exercise capacity in patients with prior myocardial infarction (MI), echocardiographic measures of LV end-diastolic/ systolic volumes, LV ejection fraction (LVEF), BNP and protein plasma levels, symptomatic heart failure, and life quality.

Eligibility criteria: Inclusion Criteria:

1. Acute myocardial infarction (AMI) within 1 months prior to recruitment;
2. Aged 18 years or over and under 80 years;
3. Randomized patients will have been hemodynamically stable, SBP ≥100mmHg, no symptomatic hypotension;
4. NYHA Class Ⅱ-Ⅳ, HFrEF or HFpEF;
5. Elevated NT-proBNP or BNP at the time of screening;
6. Peak VO2/kg\<16 ml/kg/min by CPET

Exclusion Criteria:

1. Inability to complete a CPET;
2. Symptomatic hypotension and/or systolic blood pressure \<100mmHg;
3. eGFR \< 30 mL/min/1.73m2 and/or serum potassium \>5.2mmol/L;
4. History of hypersensitivity or allergy to ACE-inhibitors/ARB
5. History of angioedema;
6. Pregnancy, planning pregnancy, or breast feeding;
7. Life-threatening diseases with limited life expectancy \<1 year

Primary outcomes:
measure: Peak oxygen consumption (VO2)/kg
timeFrame: 3 months
measure: Peak Oxygen Pulse (O2-Pulse)
timeFrame: 3 months
measure: LVEF
timeFrame: 3 months
Secondary outcomes:
measure: Peak VO2/kg change
timeFrame: 6 months
measure: Peak Oxygen Pulse change
timeFrame: 6 months
measure: Ventilatory efficiency (VE/VCO2 slope) change
timeFrame: 6 months
measure: LVEF change
timeFrame: 6 months
measure: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) change
timeFrame: Baseline, 3, 6 months
measure: The MOS item short form health survey, SF-36
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital, Shanghai JiaoTong University, School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Qin Shao, M.D,Ph.D
role: STUDY_CHAIR
affiliation: RenJi Hospital
name: Jun Ma, M.D,Ph.D
role: STUDY_DIRECTOR
References: