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The Effects of Sacubitril/Valsartan on LV Remodelling and Fibrosis in Patients with HFrEF after AMI

The Effects of Sacubitril/Valsartan on LV Remodelling and Fibrosis in Patients with HFrEF after AMI

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023326
Enrollment
Unknown
Registered
2019-05-22
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients treated with Sacubitril/Valsartan / perindopril tablets; 2. Male or non-pregnant or non-lactating female patients = 18 years of age. 3. Patients with spontaneous new left ventricular acute myocardial infarction; 4. LVEF =45% after AMI presentation; 5. Hemodynamically stable defined as: SBP = 95mmHg ( patients who received ACEi/ARB before) SBP = 100 mmHg ( patients who did not receive ACEi/ARB before) 6. The subjects volunteered to join the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to the study drugs or drugs of similar chemical classes or known intolerance or contraindications to study drugs or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors; 2. Patients with a known history of angioedema; 3. Known history of chronic HF prior to Screening; 4. Cardiogenic shock within the last 24 hours prior to Screening; 5. Persistent clinical HF at the time of Screening; 6. Coronary artery bypass graft (CABG) performed or planned; 7. Combined with right ventricular MI; 8. Symptomatic hypotension at screening; 9. Stroke or transient ischemic attack within one month prior to Screening; 10. Known or suspected bilateral renal artery stenosis; 11. Clinically significant obstructive cardiomyopathy; 12. Open-heart surgery performed within one month prior to Screening; or planned cardiac surgery w/in the 3 months prior to Screening; 13. eGFR 5.2 mmol /L; 15. Known hepatic impairment (as evidenced by total bilirubin > 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices; 16. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 3 years with a life expectancy of less than 1 year. 17. Those who were participating in another clinical trial had not yet reached the end of the study or were planning to participate in another clinical trial within six months of taking the drug.

Design outcomes

Primary

MeasureTime frame
LVEF;Left ventricular volume;Left ventricular diameter;Left ventricular fibrosis;

Countries

China

Contacts

Public ContactZhang Bo

The First Affiliated Hospital of Dalian Medical University

zhangbo2674@163.com+86 18098875726

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026