Skip to content

Comparison of ARNI and ARB in the treatment of elderly patients with acute decompensated ejection fraction preserved heart failure

A prospective study of sacubitril and valsartan in the treatment of elderly patients with acute decompensated ejection fraction preserved heart failure

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035327
Enrollment
Unknown
Registered
2020-08-08
Start date
2020-08-17
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

heart failure

Interventions

ARNI group:ARNI 24/26mg bid
49/51mg bid
97/103mg bid
ARB group:ARB 40mg bid
80mg bid
160mg bid

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
75 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged >= 75 years, no limitation of gender; 2) New York Heart Function Association (NYHA) of ADHF inpatients (with symptoms and signs of fluid retention): Grade II-IV heart failure; 3) ADHF >= 24 hours and = 40% (based on echocardiography, MUGA, CT, MRI or ventricular angiography); N-terminal pro-B natriuretic peptide (NT-proBNP) >= 1800 ng/L in the past 6 months or B-type natriuretic peptide (BNP) >= 400 pg/ml; 5) Hemodynamically stable, defined as patients receiving ACEI/ARB treatment within 24 hours before randomization, systolic blood pressure (SBP) >= 100 mmHg at random; patients who did not receive ACEI/ARB treatment within 24 hours before randomization, SBP >= 110mmHg at random; No intravenous diuretics, vasodilators, blood pressure boosters, and / or positive inotropic drugs within the first 24 hours; 6) Informed consent.

Exclusion criteria

Exclusion criteria: 1) Symptomatic hypotension; 2) History of angioedema; 3) Known or suspected bilateral renal artery stenosis; 4) Calculate eGFR 5.3 mmol / L when randomized; 6) Liver injury (if tested, total bilirubin> 3.0 mg / dL or elevated ammonia levels), or evidence of liver cirrhosis with portal hypertension, such as esophageal varices; 7) Have a history of allergies to research drugs or other drugs in similar chemical categories; 8) History of malignant tumors of any organ system (except localized skin basal cell carcinoma) in the past 3 years, and life expectancy is less than 1 year; 9) History or evidence of drug or alcohol abuse in the past 12 months; 10) The patient was deemed unsuitable to participate in the study, including mental, behavioral, or cognitive impairments that were sufficient to affect the patient's ability to understand, obey the protocol, or complete follow-up procedures.

Design outcomes

Primary

MeasureTime frame
NT-proBNP;

Secondary

MeasureTime frame
Heart structure;NYHA classification;KCCQ;Heart failure rehospitalization;Cardiovascular mortality;

Countries

China

Contacts

Public ContactLiang Jing

Shanghai General Hospital

395234463@qq.com+86 13817286025

Outcome results

None listed

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