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

August 6, 2023 updated by: Beijing Friendship Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Rongchong Huang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hypertensive patients stratified by BMI.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sacubitril/valsartan group
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: 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.
ACEI/ARB group

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on left ventricular ejection fraction (LVEF)
Time Frame: 6 months
Changes on LVEF in % assessed with the use of cardiac magnetic resonance (CMR).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on blood pressure
Time Frame: 12 months
Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.
12 months
Changes on left ventricular end-systolic diameter (LVESD)
Time Frame: 6 months
Changes on LVESD in mm assessed with the use of CMR.
6 months
Changes on left ventricular end-diastolic diameter (LVEDD)
Time Frame: 6 months
Changes on LVEDD in mm assessed with the use of CMR.
6 months
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.
6 months
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.
6 months
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.
12 months
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
12 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Principal Investigator: Rongchong Huang, M.D., Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-P2-173-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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