ARNI or ARB for residual left ventricular remodeling after primary valve regurgitation surgery: a prospective randomized controlled study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000038895

Enrollment

Unknown

Registered

2020-10-09

Start date

2020-10-31

Completion date

Unknown

Last updated

2022-01-24

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

Conditions

Left ventricular remodeling after valvular regurgitant surgery

Interventions

ARNI group:ARNI

ARB gorup:ARB

control group:Treatment withdrawal

experimental group:Continue treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged over 18 years; 2. Patients with aortic regurgitation and / or mitral regurgitation (moderate or above) after surgery; 3. 7-14 days after operation, transthoracic echocardiography showed that patients with left ventricular end diastolic diameter > 60 mm or left ventricular ejection fraction < 50%.

Exclusion criteria

Exclusion criteria: 1.Secondary MR; 2.Moderate or more severe AS; 3.Moderate or more severe MS; 4.Prior history of cardiac surgery or transcatheter interventions; 5.Known cardiomyopathies; 6.Severe CAD (defined as a history of prior myocardial infarction, coronary revascularization, or significant angiographic coronary stenosis as epicardial artery with >= 70% diameter stenosis or left main >= 50%); 7.Severe systemic disease; 8.Untreated, uncontrolled or resistant hypertension (defined as >= 3 BP-lowering drugs); 9.Expected survival < 1 year; 10.Contraindicated to ACEI/ARB/ARNI use; 11.ACEI/ARB/ARNI use not suspendable or replaceable; 12.Moderate or more severe paravalvular leakage by TTE 7-14 days after valve surgery; 13.Any severe condition after surgery which the clinicians regard as inappropriate for enrolment, including any type of shock, hemodynamically unstable arrhythmias, re-exploration, aborted cardiac arrest, dialysis, disturbance of consciousness, and thromboembolic events; 14.Informed consent not obtained.

Design outcomes

Primary

Measure	Time frame
Left ventricular ejection fraction;Left ventricular end-diastolic dimension;	—

Secondary

Measure	Time frame
Cardiovascular mortality;Heart failure hospitalization;Quality of life;6 minutes walk distance;	—

Countries

China

Contacts

Public ContactZhang Qing

West China Hospital of Sichuan University

qzhang2000cn@163.com+86 18980601267

Outcome results

None listed

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