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

ConditionsSacubitril/ValsartanHypertensionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorBeijing Friendship Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with essential hypertension

18-70 years old

No major barriers to provide written consent

Disqualifiers

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

Trial population

Hypertensive patients stratified by BMI.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Sacubitril/valsartan group1 intervention
Group B: ACEI/ARB group1 intervention

Trial outcomes

Primary outcomes

1

Changes on left ventricular ejection fraction (LVEF)

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

Time frame
6 months

Secondary outcomes

1

Changes on left ventricular end-systolic diameter (LVESD)

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

Time frame
6 months
2

Changes on left ventricular end-diastolic diameter (LVEDD)

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

Time frame
6 months
3

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.

Time frame
6 months
4

Major adverse cardiac events

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov
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