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Resistant HypertensionPhase 3NCT05545059

Effects and Safety of Sacubitril/Valsartan on Refractory Hypertension

A Phase 3 study testing Sacubitril/valsartan and valsartan in people with Resistant Hypertension, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Resistant hypertension (RH) accounted for a considerable proportion of patients with hypertension. It has been revealed to impose certain adverse effects on the prognosis of patients with cardiovascular diseases. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Resistant Hypertension
What is being tested?
Sacubitril/valsartan and valsartan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteChina
Study dates
24 Sep 2022to 31 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of resistant hypertension
  • ≥18 and ≤75 years old at the time of randomization
  • Must agree to comply with all requirements and sign the informed consent form

Who cannot join

  • unwilling to sign informed consent.
  • Severe renal insufficiency
  • Research related drug contraindications
  • secondary hypertension
  • Cardiovascular event
  • Persistent arrhythmia, valvular heart disease, and class III-IV heart failure or left ventricular ejection fraction <45%.
Show all 17Show fewer
  • Severe liver function impairment (Child-Pugh C), biliary cirrhosis and/or cholestasis
  • History of angioedema and asthma
  • Woman of childbearing age who do not take effective contraceptive measures or pregnant or breastfeeding
  • Allergic to drugs related to the study
  • Suffering from serious tumor-related diseases, receives tumor-related treatment, or has a life expectancy of less than 2 years
  • Planning to join other clinical trials
  • Anticipated changes in medical conditions
  • Need to take study-related drugs for reasons other than hypertension
  • Suffering from other diseases that may prevent the patient from participating fully period of the study
  • Other any concomitant conditions
  • Must continuously take any drugs that affect the results

Trial locations and contacts

1 site in 1 country.

Dengfeng Geng, Dr. contact

020-81332623

dr.dfengg@hotmail.com

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

    Dengfeng Geng, Dr., 020-81332623, dr.dfengg@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: Effects and Safety of Sacubitril/Valsartan Versus Valsartan on Refractory Hypertension: The EOSORH Trial

Resistant hypertension (RH) accounted for a considerable proportion of patients with hypertension. It has been revealed to impose certain adverse effects on the prognosis of patients with cardiovascular diseases. The antihypertensive effect of sacubitril/valsartan being fully confirmed in previous studies, there were no related randomized controlled trials (RCT) about this potency among Chinese patients with RH. The investigators designed this study to evaluated effects and safety of sacubitril/valsartan versus valsartan on Chinese patients with RH.

Read the detailed description

Background Resistant hypertension (RH) accounted for a considerable proportion of patients with hypertension. It has been revealed to impose certain adverse effects on the prognosis of patients with cardiovascular diseases. The antihypertensive effect of sacubitril/valsartan being fully confirmed in previous studies, there were no related randomized controlled trials (RCT) about this potency among Chinese patients with RH.

Purpose Describing the design of the Effects of Sacubitril/valsartan Versus Valsartan on Refractory Hypertension (EOSORH) trial.

Methods and analysis This is a monocentric, randomized, parallel-group, controlled trial which will investigate the efficacy and safety of sacubitril/valsartan in the treatment of Chinese patients with RH. A total of 138 patients will be enrolled who are diagnosed with RH according to the Guidelines for Prevention and Treatment of Hypertension in China (2018 revision). After a washout period, subjects will be randomized to sacubitril/valsartan group or valsartan group in a 1:1 ratio. The primary outcome is the change in 24 hours average ambulatory systolic blood pressure (SBP) from baseline to 8 weeks after randomization, comparing the sacubitril/valsartan group with valsartan group. The secondary outcomes including change in 24 hours average ambulatory diastolic blood pressure (DBP), clinic blood pressure and series of cardiac and renal hematologic indicators. Safety endpoints will also be evaluated, covered changes in blood potassium level, renal function, hypotension, etc. Full Analysis Set (FAS), per-protocol set (PPS) and safety set (SS) will be defined. Baseline data will be analyzed by using data from FAS whereas the analysis of primary outcome will be based on FAS and PPS but the conclusions of FAS are dominant.

Ethics and dissemination The research protocol has been approved by the Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University. This research is designed to investigate the efficacy and safety of sacubitril/valsartan in Chinese RH patients. Findings will be shared by Sun Yat-sen Memorial Hospital, policymakers and the academic community to promote the clinical pharmacal therapy of RH in China.

Discussion The effects of sacubitril/valsartan on hypertension have been widely reported by a series of large RCT in recent years, while its application in RH patients is still elusive. The study will provide a new pharmacal strategy for the treatment of RH.

Being tested
Sacubitril/valsartan, valsartan
Keywords
Resistant hypertension, ambulatory blood pressure, sacubitril/valsartan, valsartan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacubitril/valsartanDrug

    Also called amlodipine 10mg, hydrochlorothiazide 25 mg, spironolactone 20 mg

    In sacubitril/valsartan group, patients will receive amlodipine 10mg, hydrochlorothiazide 25 mg, spironolactone 20 mg, sacubitril/valsartan 200mg to treat. The initial dose of sacubitril/valsartan will be 100mg per day and will be doubled to 200mg per day after 2 weeks then maintain until the end of the 8-week treatment period.

  • valsartanDrug

    Also called amlodipine 10mg, hydrochlorothiazide 25 mg, spironolactone 20 mg

    In valsartan group, patients will receive amlodipine 10mg, hydrochlorothiazide 25 mg, spironolactone 20 mg and valsartan 160mg. The initial dose of valsartan will be 80mg per day and will be doubled to 160mg per day 2 weeks later and then maintain until the end of the 8-week treatment period.

Study groups in NCT05545059
Study groupRoleWhat they receive
sacubitril/valsartan groupExperimentalThe experimental group will be sacubitril/valsartan group. Patients assigned to this group will receive sacubitril/valsartan 200mg added to existing medication regimens before randomization including amlodipine 10mg per day, hydrochlorothiazide 25 mg per day, spironolactone 20 mg per day. The initial dose of sacubitril/valsartan will be 100mg per day and will be doubled to 200mg per day after 2 weeks then maintain until the end of the 8-week treatment period.
Receives: Drug: Sacubitril/valsartan
valsartan groupActive comparatorThe control group will be valsartan group, which patients will receive valsartan 160mg added to existing medication regimens before randomization including amlodipine 10mg per day, hydrochlorothiazide 25 mg per day, spironolactone 20 mg per day. The initial dose of valsartan will be 80mg per day and will be doubled to 160mg per day 2 weeks later and then maintain until the end of the 8-week treatment period.
Receives: Drug: valsartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the change in 24 hours average ambulatory systolic pressure from baseline to 8 weeks after randomization

    the change in 24 hours average ambulatory systolic blood pressure (in mmHg) from baseline to 8 weeks after randomization

    Measured: 8 weeks after randomization

Secondary outcomes (19)

  1. Change in 24 hours average ambulatory diastolic blood pressure, daytime and night-time blood pressure and office blood pressure

    Change in 24 hours average ambulatory diastolic blood pressure, daytime systolic blood pressure, night-time systolic blood pressure, daytime diastolic blood pressure, night-time diastolic blood pressure, office systolic blood pressure and office diastolic blood pressure

    Measured: 8 weeks after randomization

  2. Change in level of cardiac marker reflecting the heart failure

    serum N-terminal pro-brain natriuretic peptide (NT-proBNP in pg/ml)

    Measured: 8 weeks after randomization

  3. Change in level of cardiac marker reflecting myocardial damage

    cardiac troponin T (cTnT in pg/ml)

    Measured: 8 weeks after randomization

  4. Change in level of novel cardiac marker reflecting the heart failure

    suppression of Tumorigenicity 2 (sST2 in ng/ml)

    Measured: 8 weeks after randomization

  5. Change in level of cardiac marker reflectting myocardial metabolism

    cyclic guanosine monophosphate (cGMP in pmol/l)

    Measured: 8 weeks after randomization

  6. Change in level of estimated glomerular filtration rate

    Change in level of estimated glomerular filtration rate (eGFR in mL/min/1.73m^2).

    Measured: 8 weeks after randomization

  7. Change in level of urinary albumin to creatinine ratio

    Change in level of urinary albumin to creatinine ratio (in mg/mmol).

    Measured: 8 weeks after randomization

  8. the control rate of blood pressure

    The control rate of blood pressure. Blood pressure control was defined as a blood pressure of less than 140/90 mmHg after medical treatment.

    Measured: 8 weeks after randomization

  9. Change in left atrium diameter determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in left atrium diameter (LA in mm) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.

    Measured: 8 weeks after randomization

  10. Change in left ventricular mass index determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in left ventricular mass index (LVMI in g/m^2) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.

    Measured: 8 weeks after randomization

  11. Change in left ventricular end diastolic volume index determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in left ventricular end diastolic volume index (LVEDVI in ml/m^2) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.

    Measured: 8 weeks after randomization

  12. Change in left ventricular end systolic volume index determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in left ventricular end systolic volume index (LVESVI in ml/m^2) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.

    Measured: 8 weeks after randomization

  13. Change in left ventricular ejection fraction determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in left ventricular ejection fraction (LVEF in %) determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.

    Measured: 8 weeks after randomization

  14. Change in E/A determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in E/A determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.The E/A ratio is an echocardiographic index that reflects the diastolic function of the heart Under normal circumstances, E/A > 1.

    Measured: 8 weeks after randomization

  15. Change in E/e' determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in E/e' determined by ultrasonic cardiogram and three-dimensional .The E/E' ratio is of great clinical significance in determining the diastolic function of the heart. If the E/E' ratio is <8, diastolic dysfunction can generally be ruled out. If the E/E' ratio is > 15, it generally indicates the existence of diastolic dysfunction.

    Measured: 8 weeks after randomization

  16. Change in left ventricular overall longitudinal peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in left ventricular overall longitudinal peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.

    Measured: 8 weeks after randomization

  17. Change in overall radial peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in overall radial peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.

    Measured: 8 weeks after randomization

  18. Change in overall circumstantial peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in overall circumstantial peak strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.

    Measured: 8 weeks after randomization

  19. Change in area strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging

    Change in area strain determined by ultrasonic cardiogram and three-dimensional speckle tracking imaging.

    Measured: 8 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start24 Sep 2022 (estimated)
  3. Primary completion28 Oct 2022 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545059
Sponsor's protocol ID
2020-KY-126
Status last verified
Nov 2021
First submitted
5 Jan 2022
Last updated
19 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.

    PubMed 18574054

  • Lamirault G, Artifoni M, Daniel M, Barber-Chamoux N, Nantes University Hospital Working Group On Hypertension. Resistant Hypertension: Novel Insights. Curr Hypertens Rev. 2020;16(1):61-72. doi: 10.2174/1573402115666191011111402.

    PubMed 31622203

  • Ettehad D, Emdin CA, Kiran A, Anderson SG, Callender T, Emberson J, Chalmers J, Rodgers A, Rahimi K. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016 Mar 5;387(10022):957-967. doi: 10.1016/S0140-6736(15)01225-8. Epub 2015 Dec 24.

    PubMed 26724178

  • Kario K, Shin J, Chen CH, Buranakitjaroen P, Chia YC, Divinagracia R, Nailes J, Hoshide S, Siddique S, Sison J, Soenarta AA, Sogunuru GP, Tay JC, Teo BW, Turana Y, Zhang Y, Park S, Van Minh H, Wang JG. Expert panel consensus recommendations for ambulatory blood pressure monitoring in Asia: The HOPE Asia Network. J Clin Hypertens (Greenwich). 2019 Sep;21(9):1250-1283. doi: 10.1111/jch.13652.

    PubMed 31532913

  • Kario K, Sun N, Chiang FT, Supasyndh O, Baek SH, Inubushi-Molessa A, Zhang Y, Gotou H, Lefkowitz M, Zhang J. Efficacy and safety of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Asian patients with hypertension: a randomized, double-blind, placebo-controlled study. Hypertension. 2014 Apr;63(4):698-705. doi: 10.1161/HYPERTENSIONAHA.113.02002. Epub 2014 Jan 20.

    PubMed 24446062

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacubitril/valsartan and valsartan in people with Resistant Hypertension, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 17 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dengfeng Geng, Dr. (020-81332623, dr.dfengg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the change in 24 hours average ambulatory systolic pressure from baseline to 8 weeks after randomization (time frame: 8 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05545059, which also lists 5 linked publications.

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 19 Sep 2022.

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