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Recruiting NCT05498675

Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study

— Observational Sacubitril/Valsartan Hypertension Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sacubitril / Valsartan Oral Tablet [Entresto], ACEI/ARB.
Who it may be relevant to
Registry conditions: Sacubitril/Valsartan, Hypertension, Obesity. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Sacubitril/Valsartan on Cardiac Function Assessed by Cardiac Magnetic Resonance (CMR) in Hypertensive Patients Stratified by Body Mass Index (BMI): A Real World Study

Overview

The purpose of this study is to investigate the effect of sacubitril/valsartan on cardiac function assessed by cardiac magnetic resonance (CMR) in hypertensive patients stratified by BMI.

Detailed description

Obesity is one of the risk factors of hypertension, and affects cardiac structure and function in the long term for hypertensive patients. Sacubitril/valsartan is regarded as a better antihypertensive drug for the improvement of cardiac function for patients with heart failure, but it remains unclear whether there are differences among different BMI groups. Therefore, the aim of this study was to evaluate the benefit of sacubitril/valsartan versus other antihypertensive drugs on cardiac structure and function assessed by CMR in hypertensive patients stratified by BMI in the real world.

Interventions

  • Drug Sacubitril / Valsartan Oral Tablet [Entresto]
    There is no treatment allocation. Patients administered sacubitril / valsartan oral tablet (Entresto) 200mg 1/day by prescription that have started before inclusion of the patient enrolled into the study and defined as sacubitril/valsartan group.
  • Drug ACEI/ARB
    There is no treatment allocation. Patients administered angiotensin-converting enzyme inhibitors/angiotensin II receptor antagonists (ACEI/ARB) by prescription that have started before inclusion of the patient enrolled into the study and defined as ACEI/ARB group. Including: benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril, azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan.

Primary outcome measures

  • Changes on left ventricular ejection fraction (LVEF) [Time frame: 6 months]
Secondary outcome measures (8)
  • Changes on left ventricular end-systolic diameter (LVESD) [Time frame: 6 months]
  • Changes on left ventricular end-diastolic diameter (LVEDD) [Time frame: 6 months]
  • Changes on cardiac systolic function [Time frame: 6 months]
  • Major adverse cardiac events [Time frame: 6 months]
  • Major adverse cardiac events [Time frame: 12 months]
  • Changes on hypertension-mediated target organ damage [Time frame: 12 months]
  • Changes on blood pressure [Time frame: 6 months]
  • Changes on blood pressure [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Patients with essential hypertension
  • 18-70 years old
  • No major barriers to provide written consent

Exclusion criteria

  • Secondary hypertension, except because of sleep apnea
  • cardiovascular disease (myocardial infarction, heart failure, stroke or coronary revascularization) within 6 months
  • Severe concomitant diseases (autoimmune disease, malignancy, late stage of liver diseases, respiratory diseases and digestive diseases)
  • Unable to understand or comply with the study procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Friendship Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT05498675 · 2022-P2-173-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗