Early Treatment of ARNI on Myocardial Remodeling and Progress
1 other identifier
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedApril 14, 2020
March 1, 2020
1 year
April 8, 2020
April 12, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Peak oxygen consumption (VO2)/kg
Difference in the interval change from baseline in peak VO2/kg at 3 months following sacubitril/valsartan from 25mg/b.i.d, 50mg b.i.d, to target dosage 100mg b.i.d for 3 months, when compared with the interval change in perindopril from 2mg q.d, 4mg q.d, to target dosage 8mg q.d for 3 months.
3 months
Peak Oxygen Pulse (O2-Pulse)
Difference in the interval change from baseline in peak O2-Pulse at 3 months following sacubitril/valsartan or perindopril.
3 months
LVEF
Difference in the interval changes from baseline in left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular end-diastolic volume (LVEDV) by echocardiography assessment at 3 months, comparing sacubitril/valsartan with perindopril.
3 months
Secondary Outcomes (6)
Peak VO2/kg change
6 months
Peak Oxygen Pulse change
6 months
Ventilatory efficiency (VE/VCO2 slope) change
6 months
LVEF change
6 months
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) change
Baseline, 3, 6 months
- +1 more secondary outcomes
Study Arms (2)
Experimental: sacubitril/valsartan
EXPERIMENTALsacubitril/valsartan will be applied from 25mg b.i.d to 100mg b.i.d. for 3 months
Active Comparator: perindopril
ACTIVE COMPARATORperindopril will be applied from 2mg q.d, to 8mg q.d for 3 months
Interventions
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
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
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.
An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 3 months, 6 months later.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
RenJi Hospital, Shanghai JiaoTong University, School of Medicine
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Qin Shao, M.D,Ph.D
RenJi Hospital
- STUDY DIRECTOR
Jun Ma, M.D,Ph.D
RenJi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 13, 2020
Study Start
May 1, 2020
Primary Completion
May 1, 2021
Study Completion
December 30, 2021
Last Updated
April 14, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share