Early Treatment of ARNI on Myocardial Remodeling and Progress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental: sacubitril/valsartan

sacubitril/valsartan will be applied from 25mg b.i.d to 100mg b.i.d. for 3 months

Group Type EXPERIMENTAL

sacubitril/valsartan

Intervention Type DRUG

sacubitril/valsartan will be applied from 25mg/b.i.d for 1-2 weeks,50mg b.i.d for 2 weeks, to target dosage 100mg b.i.d for 3 months unless severe safety outcome occurs

Cardiopulmonary Exercise Test

Intervention Type OTHER

All patients will undergo a first CPET prior to initiation of treatment, a second one after 3 months, and a third one after 6 months of treatment.

Echocardiogram

Intervention Type OTHER

An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 3 months, 6 months later.

Active Comparator: perindopril

perindopril will be applied from 2mg q.d, to 8mg q.d for 3 months

Group Type ACTIVE_COMPARATOR

perindopril

Intervention Type DRUG

Drug: perindopril will be applied from 2mg for q.d for 1-2 weeks, 4mg q.d 2 weeks, to target dosage 8mg q.d for 3 months unless severe safety outcome occur

Cardiopulmonary Exercise Test

Intervention Type OTHER

All patients will undergo a first CPET prior to initiation of treatment, a second one after 3 months, and a third one after 6 months of treatment.

Echocardiogram

Intervention Type OTHER

An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 3 months, 6 months later.

Interventions

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sacubitril/valsartan

sacubitril/valsartan will be applied from 25mg/b.i.d for 1-2 weeks,50mg b.i.d for 2 weeks, to target dosage 100mg b.i.d for 3 months unless severe safety outcome occurs

Intervention Type DRUG

perindopril

Drug: perindopril will be applied from 2mg for q.d for 1-2 weeks, 4mg q.d 2 weeks, to target dosage 8mg q.d for 3 months unless severe safety outcome occur

Intervention Type DRUG

Cardiopulmonary Exercise Test

All patients will undergo a first CPET prior to initiation of treatment, a second one after 3 months, and a third one after 6 months of treatment.

Intervention Type OTHER

Echocardiogram

An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 3 months, 6 months later.

Intervention Type OTHER

Other Intervention Names

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CPET ECHO

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No