Sacubitril/ValsartanNCT05498675
Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
An observational study of Sacubitril/Valsartan and Hypertension, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sacubitril/Valsartan, Hypertension, Obesity
- What is being tested?
- Sacubitril / Valsartan Oral Tablet [Entresto] and ACEI/ARB
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertensive patients stratified by BMI.
Who may be able to join
- Patients with essential hypertension
- 18-70 years old
- No major barriers to provide written consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Rongchong Huang, M.D., +86-13811039417, rchuang@ccmu.edu.cn
Rongchong Huang, M.D.
About this study
Official 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
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.
Read the 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.
- Conditions
- Sacubitril/Valsartan, Hypertension, Obesity
- Being tested
- Sacubitril / Valsartan Oral Tablet [Entresto], ACEI/ARB
- Keywords
- Cardiac function, Cardiac magnetic resonance
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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/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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ACEI/ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on left ventricular ejection fraction (LVEF)
Changes on LVEF in % assessed with the use of cardiac magnetic resonance (CMR).
Measured: 6 months
Secondary outcomes (8)
Changes on left ventricular end-systolic diameter (LVESD)
Changes on LVESD in mm assessed with the use of CMR.
Measured: 6 months
Changes on left ventricular end-diastolic diameter (LVEDD)
Changes on LVEDD in mm assessed with the use of CMR.
Measured: 6 months
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.
Measured: 6 months
Major adverse cardiac events
Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.
Measured: 6 months
Major adverse cardiac events
Including all-cause mortality, cardiac death, acute myocardial infarction, stroke, heart failure, ventricular tachycardia or ventricular fibrillation requiring shock delivery.
Measured: 12 months
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
Measured: 12 months
Changes on blood pressure
Changes on systolic and blood pressure assessed with the use of 24-hour ambulatory blood pressure monitoring (ABPM).
Measured: 6 months
Changes on blood pressure
Changes on systolic and blood pressure assessed with the use of 24-hour ABPM.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacubitril/ValsartanStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rongchong Huang, M.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498675
- Sponsor's protocol ID
- 2022-P2-173-01
- Status last verified
- Feb 2025
- First submitted
- 1 Aug 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05498675
- Acronym / sponsor ID
- 2022-P2-173-01
- Conditions
- Sacubitril/Valsartan, Hypertension, Obesity
- Keywords
- Cardiac function, Cardiac magnetic resonance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/valsartan group | – | Drug: Sacubitril / Valsartan Oral Tablet [Entresto]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 | – | Drug: ACEI/ARBPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive patients stratified by BMI.
Key inclusion criteria (3 listed)
- Patients with essential hypertension
- 18-70 years old
- No major barriers to provide written consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Sacubitril/valsartan group |
| ACEI/ARBThere 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. | Drug | ACEI/ARB group |
Primary outcome
Changes on left ventricular ejection fraction (LVEF)
Time frame: 6 months
Changes on LVEF in % assessed with the use of cardiac magnetic resonance (CMR).
8 secondary outcomes
Changes on left ventricular end-systolic diameter (LVESD)
Time frame: 6 months
Changes on left ventricular end-diastolic diameter (LVEDD)
Time frame: 6 months
Changes on cardiac systolic function
Time frame: 6 months
Major adverse cardiac events
Time frame: 6 months
Major adverse cardiac events
Time frame: 12 months
Changes on hypertension-mediated target organ damage
Time frame: 12 months
Changes on blood pressure
Time frame: 6 months
Changes on blood pressure
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Sacubitril/Valsartan
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
RecruitingObservational study
A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy in Hypertensive Patients in the United Arab Emirates
Hypertension
RecruitingPhase 3
Effect of Sacubitril-Valsartan on Cardiac Structure and Function
Congenital Heart Disease
Not yet recruitingPhase 1
[11C]PS13 PET Imaging of Neuroinflammation in Heart Failure With Reduced Ejection Fraction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rongchong Huang, M.D. principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacubitril/Valsartan and Hypertension, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rongchong Huang, M.D. (+86-13811039417, rchuang@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on left ventricular ejection fraction (LVEF) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.