Chronic Heart Failure
Conditions
Keywords
Shakurba valsartan, Heart failure, ACEI/ARB
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Baoji Central Hospital
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * HFrEF, defined as LVEF≤40% and New York Heart Association (NYHA) class ≥ II. * Plasma NT-proBNP ≥ 600 pg/ml, or NT-proBNP ≥ 400 pg/ml if patients have been hospitalized for heart failure in 12 months. * If patients have been taking ACEI/ARB at recruitment, a stable dose equivalent to at least 10mg/day of enalapril will be required. * Volunteer for the study and sign the informed consent.
Exclusion criteria
* Symptomatic hypotension, systolic blood pressure \< 95 mmHg at baseline. * eGFR \< 30 ml(/min\*1.73m2) at baseline. * Serum potassium \> 5.4 mmol/L at baseline. * Contraindication of ACEI or ARB.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular events | 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 | Composite outcomes of all-cause death including cardiac death and re-hospitalization due to heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-minutes walking test | Test in 1, 3, 6, 12 months comparing to the baseline. | A test evaluating cardiac function. |
| LVEF | Test in 1, 3, 6, 12 months comparing to the baseline. | Left ventricular ejection fraction. |
Countries
China
Contacts
Primary ContactYihui Xiao
Backup ContactYihui Xiao
Outcome results
None listed