Myocardial InfarctionPhase 4NCT04342351
Early Treatment of ARNI on Myocardial Remodeling and Progress
A Phase 4 study testing sacubitril/valsartan, perindopril and Cardiopulmonary Exercise Test in people with Myocardial Infarction, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- sacubitril/valsartan, perindopril and Cardiopulmonary Exercise Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 30 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
RenJi Hospital, Shanghai JiaoTong University, School of Medicine
Shanghai, Shanghai Municipality, 200127
Qin Shao, M.D,Ph.D, 86-21-68385225, shaoqindr@126.com
Jun Ma, M.D,Ph.D, 86-21-68383164, drjunma@126.com
About this study
Official title: Early Treatment of ARNI on Myocardial Remodeling and Progress in Patients With Post-AMI (EARLYmyo-CRPⅠ)
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- sacubitril/valsartan, perindopril, Cardiopulmonary Exercise Test, Echocardiogram
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacubitril/valsartanDrug
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
perindoprilDrug
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 TestOther
Also called CPET
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.
EchocardiogramOther
Also called ECHO
An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 3 months, 6 months later.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: sacubitril/valsartan | Experimental | sacubitril/valsartan will be applied from 25mg b.i.d to 100mg b.i.d. for 3 months Receives: Drug: sacubitril/valsartan; Other: Cardiopulmonary Exercise Test; Other: Echocardiogram |
| Active Comparator: perindopril | Active comparator | perindopril will be applied from 2mg q.d, to 8mg q.d for 3 months Receives: Drug: perindopril; Other: Cardiopulmonary Exercise Test; Other: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (6)
Peak VO2/kg change
Difference in the interval changes from baseline and 6 months in peak VO2 comparing sacubitril/valsartan with perindopril.
Measured: 6 months
Peak Oxygen Pulse change
Difference in the interval changes from baseline and 6 months in peak O2-Pulse comparing sacubitril/valsartan with perindopril.
Measured: 6 months
Ventilatory efficiency (VE/VCO2 slope) change
Difference in the interval changes from baseline and 6 months in the VE/VCO2 slope comparing sacubitril/valsartan with perindopril.
Measured: 6 months
LVEF change
Difference in the interval changes from baseline in LVEF, LVESV, and left LVEDV at 6 months, comparing sacubitril/valsartan with perindopril.
Measured: 6 months
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) change
Change in concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 3 months , 6 months.
Measured: Baseline, 3, 6 months
The MOS item short form health survey, SF-36
A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts. The higher scores mean a better outcome.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qin Shao, M.D,Ph.D, Study chair, RenJi HospitalJun Ma, M.D,Ph.D, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342351
- Sponsor's protocol ID
- CRP
- Status last verified
- Mar 2020
- First submitted
- 8 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment of ARNI on Myocardial Remodeling and Progress in Patients With Post-AMI (EARLYmyo-CRPⅠ)
- ClinicalTrials.gov ID
- NCT04342351
- Acronym / sponsor ID
- CRP
- Conditions
- Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: sacubitril/valsartan | Experimental | Drug: sacubitril/valsartan, Other: Cardiopulmonary Exercise Test, Other: Echocardiogramsacubitril/valsartan will be applied from 25mg b.i.d to 100mg b.i.d. for 3 months |
| Active Comparator: perindopril | Active comparator | Drug: perindopril, Other: Cardiopulmonary Exercise Test, Other: Echocardiogramperindopril will be applied from 2mg q.d, to 8mg q.d for 3 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacubitril/valsartansacubitril/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 | Experimental: sacubitril/valsartan |
| perindoprilDrug: 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 | Drug | Active Comparator: perindopril |
| Cardiopulmonary Exercise TestAlso: CPETAll 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. | Other | Active Comparator: perindopril, Experimental: sacubitril/valsartan |
| EchocardiogramAlso: ECHOAn echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 3 months, 6 months later. | Other | Active Comparator: perindopril, Experimental: sacubitril/valsartan |
Primary outcome
Peak oxygen consumption (VO2)/kg
Time frame: 3 months
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.
Peak Oxygen Pulse (O2-Pulse)
Time frame: 3 months
Difference in the interval change from baseline in peak O2-Pulse at 3 months following sacubitril/valsartan or perindopril.
LVEF
Time frame: 3 months
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.
6 secondary outcomes
Peak VO2/kg change
Time frame: 6 months
Peak Oxygen Pulse change
Time frame: 6 months
Ventilatory efficiency (VE/VCO2 slope) change
Time frame: 6 months
LVEF change
Time frame: 6 months
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) change
Time frame: Baseline, 3, 6 months
The MOS item short form health survey, SF-36
Time frame: baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qin Shao, M.D,Ph.D study chair
RenJi Hospital
Jun Ma, M.D,Ph.D study director
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sacubitril/valsartan, perindopril and Cardiopulmonary Exercise Test in people with Myocardial Infarction, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Shao, M.D,Ph.D (86-21-68385225, shaoqindr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (VO2)/kg (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.