Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05498675
Other study ID # 2022-P2-173-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2024

Study information

Verified date August 2023
Source Beijing Friendship Hospital
Contact Rongchong Huang, M.D.
Phone +86-13811039417
Email rchuang@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date September 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes on left ventricular ejection fraction (LVEF) Changes on LVEF in % assessed with the use of cardiac magnetic resonance (CMR). 6 months
Secondary Changes on left ventricular end-systolic diameter (LVESD) Changes on LVESD in mm assessed with the use of CMR. 6 months
Secondary Changes on left ventricular end-diastolic diameter (LVEDD) Changes on LVEDD in mm assessed with the use of CMR. 6 months
Secondary Changes on cardiac systolic function Changes on cardiac systolic function in E/A, E-wave deceleration time (EDT) in ms assessed with the use of CMR. 6 months
Secondary Major adverse cardiac events Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery. 6 months
Secondary Major adverse cardiac events Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery. 12 months
Secondary Changes on hypertension-mediated target organ damage 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
Secondary Changes on blood pressure Changes on systolic and blood pressure assessed with the use of 24-hour ambulatory blood pressure monitoring (ABPM). 6 months
Secondary Changes on blood pressure Changes on systolic and blood pressure assessed with the use of 24-hour ABPM. 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2