Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05498675

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Sacubitril/Valsartan Body Weight Cardiovascular Diseases Hypertension Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Rongchong Huang, M.D.

CONTACT

[email protected]

+86-13811039417

Rongchong Huang, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacubitril / Valsartan Oral Tablet [Entresto]

Drug

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.

ACEI/ARB

Drug

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 outcomes

  1. Changes on left ventricular ejection fraction (LVEF)

    Time frame: 6 months

    Changes on LVEF in % assessed with the use of cardiac magnetic resonance (CMR).

Secondary outcomes

  1. Changes on left ventricular end-systolic diameter (LVESD)

    Time frame: 6 months

    Changes on LVESD in mm assessed with the use of CMR.

  2. Changes on left ventricular end-diastolic diameter (LVEDD)

    Time frame: 6 months

    Changes on LVEDD in mm assessed with the use of CMR.

  3. Changes on cardiac systolic function

    Time frame: 6 months

    Changes on cardiac systolic function in E/A, E-wave deceleration time (EDT) in ms assessed with the use of CMR.

  4. Major adverse cardiac events

    Time frame: 6 months

    Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.

  5. Major adverse cardiac events

    Time frame: 12 months

    Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.

  6. Changes on hypertension-mediated target organ damage

    Time frame: 12 months

    Change on hypertension-mediated target organ damage including the estimated glomerular filtration rate (eGFR), total cholesterol, triglycerides level, LDL-cholesterol, HDL-cholesterol, and carotid intima-media thickness (IMT) assessed by carotid ultrasound

  7. Changes on blood pressure

    Time frame: 6 months

    Changes on systolic and blood pressure assessed with the use of 24-hour ambulatory blood pressure monitoring (ABPM).

  8. Changes on blood pressure

    Time frame: 12 months

    Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.

Study contacts

Contact information is provided by the study sponsor or research team.

Rongchong Huang, M.D.

CONTACT

[email protected]

+86-13811039417

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.