Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Baoji Central Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
This study is a randomized controlled multicenter clinical trial, in which about 340 patients with newly diagnosed or prior diagnosed chronic heart will be recruited. Patients will be randomly divided into Angiotensin-Neprilysin Inhibition (ARNI) group and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEI/ARB) group. All-cause death, cardiac death and re-hospitalization due to heart failure will be evaluated in 1, 3, 6, 12 months after recruitment.
Chronic heart failure is associated with poor prognosis in cardiac patients, although systemic effective drugs has been applied in these patients. European Society of Cardiology (ESC) has recommended ARNI Sacubitril/Valsartan as first-line drugs in replacement of ACEI (I, B) in 2016 for these patients. While American College of Cardiology and The American Heart Association (ACC/AHA) made a first-line recommendation that patients with heart failure due to reduced ejection fraction (HFrEF) could be administrated ARNI directly. Hence, we apply this trial to find if ARNI could replace ACEI/ARB to provide insights for better treatment of chronic heart failure in China. This study is a randomized controlled multicenter clinical trial, in which about 340 patients with newly diagnosed or prior diagnosed chronic heart will be recruited. Patients will be randomly divided into Angiotensin-Neprilysin Inhibition (ARNI) group and ACEI/ARB group. All-cause death, cardiac death and re-hospitalization due to heart failure will be evaluated in 1, 3, 6, 12 months after recruitment. Other safety assessment including left ventricular ejection fraction (LVEF), 6 minutes walk test will be followed up as well.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly diagnosed HFrEF ARNI | Experimental | Newly diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study. |
|
| Newly diagnosed HFrEF ACEI/ARB | Active Comparator | Newly diagnosed HFrEF patients will be administered ACEI/ARB according to the clinical condition among the whole study. |
|
| Prior diagnosed HFrEF ARNI | Experimental | Prior diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study. |
|
| Prior diagnosed HFrEF ACEI/ARB | Active Comparator | Prior diagnosed HFrEF patients will be administered ACEI/ARB according to the clinical condition among the whole study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entresto | Drug | Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular events | Composite outcomes of all-cause death including cardiac death and re-hospitalization due to heart failure | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minutes walking test | A test evaluating cardiac function. | Test in 1, 3, 6, 12 months comparing to the baseline. |
| LVEF | Left ventricular ejection fraction. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yihui Xiao | Contact | +86 13572236467 | +8613572236467 | sbw_514@163.com |
| Yihui Xiao | Contact | +8613572236467 | +8613572236467 | sbw_514@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yihui Xiao | First Affiliated Hospital Xi'an Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710000 | China |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ACEI/ARB | Drug | Choose one of ACEI/ARB according to the clinical condition among the whole study. |
|
| Test in 1, 3, 6, 12 months comparing to the baseline. |