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NCT04342351
Early Treatment of ARNI on Myocardial Remodeling and Progress
Phase 4 trial testing sacubitril/valsartan in Myocardial Infarction in 280 participants. Status unknown.
1 May 2021
Quick facts
| Lead sponsor | RenJi Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 280 |
| Start date | 1 May 2020 |
| Primary completion | 1 May 2021 |
| Estimated completion | 30 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- sacubitril/valsartan
- perindopril — full drug profile →
- Cardiopulmonary Exercise Test
- Echocardiogram
Conditions studied
- Myocardial Infarction — all drugs for Myocardial Infarction →
Sponsor
RenJi Hospital
Who can join
Adults 18 to 80, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04342351
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of sacubitril/valsartan
Trials testing the same drug.
- NCT06149104 — A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle · Phase 3 · completed
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- NCT05613140 — Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure · completed
- NCT06218199 — Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts · Phase 4 · recruiting
- NCT04637555 — Open-label Extension Study for CLCZ696G2301 (PARADISE-MI) · Phase 3 · withdrawn
Other recruiting trials for Myocardial Infarction
Currently open trials in the same condition.
- NCT07257198 — Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone · Phase 3 · recruiting
- NCT07402642 — Effect of Early Educational Intervention on Cardiovascular Risk Factors After Acute Coronary Syndrome · NA · recruiting
- NCT07301034 — A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, · Phase 3 · recruiting
- NCT07142265 — Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients · recruiting
- NCT07138911 — Effect of Home-based Exercise Plan Mediated by Use of Digital Health App on Kinesiophobia and Functional Capacity · NA · recruiting
Other RenJi Hospital trials
Trials by the same sponsor.
- NCT07584733 — Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper · Phase 2 · not yet recruiting
- NCT07537725 — EEG-TMS for Postoperative Delirium After Cardiac Surgery · NA · not yet recruiting
- NCT07527936 — A Study of BEN301 Injection in theTreatment of Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
- NCT07343076 — Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE · NA · not yet recruiting
- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04342351 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RenJi Hospital
- Last refreshed: 14 April 2020
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing