NCT05498675

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Sep 2021Jun 2027

Study Start

First participant enrolled

September 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

5.3 years

First QC Date

August 1, 2022

Last Update Submit

February 11, 2025

Conditions

Sacubitril/ValsartanHypertensionObesity

Keywords

Cardiac functionCardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

  • Changes on left ventricular ejection fraction (LVEF)

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

    6 months

Secondary Outcomes (8)

  • Changes on left ventricular end-systolic diameter (LVESD)

    6 months

  • Changes on left ventricular end-diastolic diameter (LVEDD)

    6 months

  • Changes on cardiac systolic function

    6 months

  • Major adverse cardiac events

    6 months

  • Major adverse cardiac events

    12 months

  • +3 more secondary outcomes

Study Arms (2)

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]

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

Interventions

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.

Sacubitril/valsartan group
ACEI/ARBDRUG

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.

ACEI/ARB group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypertensive patients stratified by BMI.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

HypertensionObesity

Interventions

sacubitrilValsartansacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Rongchong Huang, M.D.

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongchong Huang, M.D.

CONTACT

+86-13811039417rchuang@ccmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 12, 2022

Study Start

September 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)