HypertensionPhase 4AZAFNCT05841654

Effect of Azilsartan on Atrial Fibrillation in Patients With Hypertension

A Phase 4 study testing Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNI in people with Hypertension and Atrial Fibrillation, run by Beijing Tsinghua Chang Gung Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Hypertension and atrial fibrillation (AF) are two major public health problems worldwide. Hypertension is an important risk factor for AF, and the combination of which could significantly increase the risk of cardiovascular adverse events, and result greater disability rate and mortality. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Atrial Fibrillation
What is being tested?: Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteChina
Study dates: 1 Jun 2023to 1 Oct 2025
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years.
Satisfied the diagnostic criteria for hypertension in the 2020 International Society of Hypertension Global Practice Guidelines for Hypertension.
Blood pressure control fails to meet one of the following conditions: office blood pressure ≥ 140/90mmHg; ambulatory blood pressure monitoring daytime average blood pressure ≥ 135/85mmHg or nighttime average blood pressure ≥ 120/70mmHg; home monitoring blood pressure ≥ 135/85mmHg.
Echocardiography shows that the left ventricular wall thickness is ≥11 mm, or the left ventricular mass index (LVMI) is >95 g/m2 (female), 115 g/m2 (male).

Who cannot join

Secondary hypertension.
Confirmed diagnosis of persistent atrial fibrillation.
Severe liver and kidney disease (eGFR<30 mL/min/1.73m2), severe lung disease, malignant tumor and mental illness history.
Pregnant women, women of childbearing age who plan to become pregnant during the study or who cannot use effective contraception during the study
Illness leading to life expectancy <12 months.
Not signed informed consent.

Trial locations and contacts

1 site in 1 country.

He Rong, M.D., Ph.D contact

13141094403 ext. 56119519

dr_herong@sina.com

China1 site

Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 102218
He Rong, M.D., Ph.D, 13141094403 ext. 56119519, dr_herong@sina.com

Other trials in China

About this study

Official title: Effect of Azilsartan on the Incidence of Atrial Fibrillation in Patients With Hypertension Combined With Left Ventricular Hypertrophy

Hypertension can stimulate cardiomyocytes apoptosis, drive renin-angiotensin-aldosterone system (RAAS) activation, lead to left ventricular hypertrophy (LVH) and finally result in the structure remodeling of the atrium, which can trigger AF development through influence on myocardial electrical activity. Previous studies have found that angiotensin receptor blockers (ARB) seem to be more efficient in preventing AF when hypertension combined heart failure or LVH, but not completely clear in others with hypertension.

Azilsartan is a new ARB, it replaces the tetrazole ring of the traditional ARB with the oxadiazole ring, which making it binds to the angiotensin type 1 (AT1) receptor more tightly, dissociate more slowly, and has a stronger antihypertensive effect. It was reported that Azilsartan could inhibit cell proliferation, reduce inflammation and oxidative stress. However, whether Azilsartan can reduce the risk of AF in hypertensive patients, and the possible corresponding mechanism is still unclear.

Accordingly, the investigators designed this study intending to evaluate the effect of Azilsartan on the incidence of AF in hypertensive patients combined with LVH, and to explore the possible mechanism. This study is a practical, multicenter randomized controlled research method, the investigators will include 400 patients with hypertension and LVH who meet the inclusion criteria in Beijing Tsinghua Changgung Hospital and other centers. The patients would be divided into the Azilsartan group and conventional treatment group randomly, and be followed up regularly for 12 months. The incidence of AF in the two groups would be compared through the flexible intelligent ECG monitoring system, and the optimal blood pressure control, also the left ventricular hypertrophy and left atrial function would be evaluated.

This study will provide evidence for the use of Azilsartan in blood pressure control and lower risk for AF patients with hypertension and LVH. It will be benefit for improving prognosis of patients with hypertension combined LVH, reducing the incidence of AF, and achieving good social economic effects.

Conditions: Hypertension, Atrial Fibrillation
Being tested: Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNI
Keywords: Azilsartan, Atrial Fibrillation, Hypertension, Left Ventricular Hypertrophy
Medical subject headings: Hypertension, Atrial Fibrillation, Hypertrophy, Left Ventricular

What participants receive

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

Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNIDrug
The patient's ECG information will be monitored through the ECG monitoring patch, and the time of the first atrial fibrillation event will be recorded. Monitoring whether the patient's blood pressure is controlled dynamically, using echocardiography to evaluate cardiac function, and using scales to assess the quality of life.

Study groups in NCT05841654
Study group	Role	What they receive
Azilsartan treatment group	Experimental	In the Azilsartan group, Azilsartan will be added in or switched to the original antihypertensive treatment plan, starting as 20 mg Qd, and gradually increased to 40 mg Qd according to the blood pressure. If the blood pressure is still not be controlled, antihypertensive drugs other than ACEI, ARB or ARNI will be added until the blood pressure is controlled. Receives: Drug: Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNI
Conventional treatment group	Active comparator	In the routine treatment group, antihypertensive treatment programs other than ACEI, ARB or ARNI will be adopted, and the use of antihypertensive drugs will be adjusted until the blood pressure control is controlled. Receives: Drug: Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNI

What is being measured

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

Incidence and burden of atrial fibrillation
In this study, atrial fibrillation includes both paroxysmal or persistent atrial fibrillation. Paroxysmal atrial fibrillation refers to that lasts for more than 30 seconds but less than 7 days, and the persistent one refers to that lasts over 7 days. Atrial fibrillation burden is defined as the percentage of analyzable wear time in AF.
Measured: The patient's ECG information will be recorded once a month, and be continuously monitored for 7 days at each time. A 24-hour Holter electrocardiogram was performed within 48 weeks.

Secondary outcomes (3)

Control of Blood pressure
In this study, the percentage time to achieve blood pressure target (TITRE) and ambulatory blood pressure monitoring will be used to evaluate the achievement of blood pressure target. Greater percentage time at target (TITRE) was associated with lower risk of incident cardiovascular diseases and was an effective predictor of clinical outcomes, with a high clinical relevance and actionability. The standard calculation method of TITRE is based on that reported in previous studies.
Measured: Patients will conduct self-test blood pressure 3 days a week, once in the morning and once in the evening. A 12-week interval is used to calculate the TITRE values of the two groups of patients at 0-12 weeks, 13-24 weeks, 25-36 weeks, and 37-48 weeks.
Evaluation of left ventricular hypertrophy and left atrial dimension
Two-dimensional transthoracic echocardiography (2DE) diastolic interventricular septal thickness (IVST) or left ventricular posterior wall thickness (PWT) and left ventricular mass index (LVMI) will be used to evaluate left ventricular hypertrophy. According to the guidelines, IVST or PWT ≥ 11mm, LVMI > 95g/m2 (female)/115 g/m2 (male) is defined as left ventricular hypertrophy. Left atrial dimension is evaluated by left atrial volume index (LAVI). Left atrial volume is measured by two-dimensional echocardiography, and the left atrial volume index (LAVI) is obtained by correcting body surface area.
Measured: From baseline to the end of study.
Healthy quality of life
In this study, three-level EuroQol five-dimensions (EQ-5D-3L) will be used to assess the patient's quality of life, and the difference in the change in the quality of life between the two groups will be compared. The EQ-5D-3L is a self-assessment scale which includes five dimensions: mobility, self-care, daily activities, pain or discomfort, and depression. There are three categories of options for each dimension (Normal, Moderately Restricted, Severely Restricted). This commonly used health utility measure converts quality of life and health status into quality-adjusted life years (QALYs).
Measured: From baseline to end of study

Timeline

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

1 Jun 20231 Oct 2025

First posted3 May 2023
Study start1 Jun 2023 (estimated)
Primary completion1 Jun 2025 (estimated)
Study completion1 Oct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Beijing Tsinghua Chang Gung 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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: In the study, the selected patients would be randomly divided into the Azilsartan treatment group and the conventional treatment group, and all the selected patients would be regularly followed up for 12 months. In the Azilsartan group, Azilsartan will be added in or switched to the original antihypertensive treatment plan, starting as 20 mg Qd, and gradually increased to 40 mg Qd according to the blood pressure. If the blood pressure is still not be controlled, antihypertensive drugs other than angiotensin-converting enzyme inhibitor (ACEI), ARB or angiotensin receptor blocker and neprilysin inhibitor (ARNI) will be added until the blood pressure is controlled. In the routine treatment group, antihypertensive treatment programs other than ACEI, ARB or ARNI will be adopted, and the use of antihypertensive drugs will be adjusted until the blood pressure control is controlled.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05841654
Sponsor's protocol ID: 2022-CCA-HX-009
Acronym: AZAF
Status last verified: Apr 2023
First submitted: 23 Mar 2023
Last updated: 3 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
PubMed 30700139
Zhou Z, Hu D. An epidemiological study on the prevalence of atrial fibrillation in the Chinese population of mainland China. J Epidemiol. 2008;18(5):209-16. doi: 10.2188/jea.je2008021. Epub 2008 Sep 8.
PubMed 18776706
Encephalopathy from hyponatremia. Ann Intern Med. 1990 Jul 1;113(1):84-6. doi: 10.7326/0003-4819-113-1-84_3. No abstract available.
PubMed 2350117
Gumprecht J, Domek M, Lip GYH, Shantsila A. Invited review: hypertension and atrial fibrillation: epidemiology, pathophysiology, and implications for management. J Hum Hypertens. 2019 Dec;33(12):824-836. doi: 10.1038/s41371-019-0279-7. Epub 2019 Nov 5.
PubMed 31690818
Chung SC, Pujades-Rodriguez M, Duyx B, Denaxas SC, Pasea L, Hingorani A, Timmis A, Williams B, Hemingway H. Time spent at blood pressure target and the risk of death and cardiovascular diseases. PLoS One. 2018 Sep 5;13(9):e0202359. doi: 10.1371/journal.pone.0202359. eCollection 2018.
PubMed 30183734

Want to know more?

He Rong, M.D., Ph.D

13141094403 ext. 56119519

dr_herong@sina.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Azilsartan on the Incidence of Atrial Fibrillation in Patients With Hypertension Combined With Left Ventricular Hypertrophy
ClinicalTrials.gov ID: NCT05841654
Acronym / sponsor ID: AZAF / 2022-CCA-HX-009
Conditions: Hypertension, Atrial Fibrillation
Keywords: Azilsartan, Atrial Fibrillation, Hypertension, Left Ventricular Hypertrophy
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 400 participants (estimated)
Lead sponsor: Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
Study start: 1 Jun 2023 (estimated)
Primary completion: 1 Jun 2025 (estimated)
Study completion: 1 Oct 2025 (estimated)
First posted: 3 May 2023 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: In the study, the selected patients would be randomly divided into the Azilsartan treatment group and the conventional treatment group, and all the selected patients would be regularly followed up for 12 months. In the Azilsartan group, Azilsartan will be added in or switched to the original antihypertensive treatment plan, starting as 20 mg Qd, and gradually increased to 40 mg Qd according to the blood pressure. If the blood pressure is still not be controlled, antihypertensive drugs other than angiotensin-converting enzyme inhibitor (ACEI), ARB or angiotensin receptor blocker and neprilysin inhibitor (ARNI) will be added until the blood pressure is controlled. In the routine treatment group, antihypertensive treatment programs other than ACEI, ARB or ARNI will be adopted, and the use of antihypertensive drugs will be adjusted until the blood pressure control is controlled.

Arm	Type	Receives
Azilsartan treatment group	Experimental	Drug: Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNIIn the Azilsartan group, Azilsartan will be added in or switched to the original antihypertensive treatment plan, starting as 20 mg Qd, and gradually increased to 40 mg Qd according to the blood pressure. If the blood pressure is still not be controlled, antihypertensive drugs other than ACEI, ARB or ARNI will be added until the blood pressure is controlled.
Conventional treatment group	Active comparator	Drug: Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNIIn the routine treatment group, antihypertensive treatment programs other than ACEI, ARB or ARNI will be adopted, and the use of antihypertensive drugs will be adjusted until the blood pressure control is controlled.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥ 18 years.
Satisfied the diagnostic criteria for hypertension in the 2020 International Society of Hypertension Global Practice Guidelines for Hypertension.
Blood pressure control fails to meet one of the following conditions: office blood pressure ≥ 140/90mmHg; ambulatory blood pressure monitoring daytime average blood pressure ≥ 135/85mmHg or nighttime average blood pressure ≥ 120/70mmHg; home monitoring blood pressure ≥ 135/85mmHg.
Echocardiography shows that the left ventricular wall thickness is ≥11 mm, or the left ventricular mass index (LVMI) is >95 g/m2 (female), 115 g/m2 (male).

Key exclusion criteria (6 listed)

Secondary hypertension.
Confirmed diagnosis of persistent atrial fibrillation.
Severe liver and kidney disease (eGFR<30 mL/min/1.73m2), severe lung disease, malignant tumor and mental illness history.
Pregnant women, women of childbearing age who plan to become pregnant during the study or who cannot use effective contraception during the study
Illness leading to life expectancy <12 months.

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
Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNIThe patient's ECG information will be monitored through the ECG monitoring patch, and the time of the first atrial fibrillation event will be recorded. Monitoring whether the patient's blood pressure is controlled dynamically, using echocardiography to evaluate cardiac function, and using scales to assess the quality of life.	Drug	Azilsartan treatment group, Conventional treatment group

Primary outcome

Incidence and burden of atrial fibrillation
Time frame: The patient's ECG information will be recorded once a month, and be continuously monitored for 7 days at each time. A 24-hour Holter electrocardiogram was performed within 48 weeks.
In this study, atrial fibrillation includes both paroxysmal or persistent atrial fibrillation. Paroxysmal atrial fibrillation refers to that lasts for more than 30 seconds but less than 7 days, and the persistent one refers to that lasts over 7 days. Atrial fibrillation burden is defined as the percentage of analyzable wear time in AF.

3 secondary outcomes

Control of Blood pressure
Time frame: Patients will conduct self-test blood pressure 3 days a week, once in the morning and once in the evening. A 12-week interval is used to calculate the TITRE values of the two groups of patients at 0-12 weeks, 13-24 weeks, 25-36 weeks, and 37-48 weeks.
Evaluation of left ventricular hypertrophy and left atrial dimension
Time frame: From baseline to the end of study.
Healthy quality of life
Time frame: From baseline to end of study

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
Background: PubMed 30700139Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
Background: PubMed 18776706Zhou Z, Hu D. An epidemiological study on the prevalence of atrial fibrillation in the Chinese population of mainland China. J Epidemiol. 2008;18(5):209-16. doi: 10.2188/jea.je2008021. Epub 2008 Sep 8.
Background: PubMed 2350117Encephalopathy from hyponatremia. Ann Intern Med. 1990 Jul 1;113(1):84-6. doi: 10.7326/0003-4819-113-1-84_3. No abstract available.
Background: PubMed 31690818Gumprecht J, Domek M, Lip GYH, Shantsila A. Invited review: hypertension and atrial fibrillation: epidemiology, pathophysiology, and implications for management. J Hum Hypertens. 2019 Dec;33(12):824-836. doi: 10.1038/s41371-019-0279-7. Epub 2019 Nov 5.
Background: PubMed 30183734Chung SC, Pujades-Rodriguez M, Duyx B, Denaxas SC, Pasea L, Hingorani A, Timmis A, Williams B, Hemingway H. Time spent at blood pressure target and the risk of death and cardiovascular diseases. PLoS One. 2018 Sep 5;13(9):e0202359. doi: 10.1371/journal.pone.0202359. eCollection 2018.
Individual participant dataSharing planned: Yes

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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. This study is not recruiting at the moment.

He Rong, M.D., Ph.D contact

13141094403 ext. 56119519

dr_herong@sina.com

He Rong, M.D., Ph.D study chair

Beijing Tsinghua Chang Gung Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 6 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 3 May 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 He Rong, M.D., Ph.D (13141094403 ext. 56119519, dr_herong@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and burden of atrial fibrillation (time frame: The patient's ECG information will be recorded once a month, and be continuously monitored for 7 days at each time. A 24-hour Holter electrocardiogram was performed within 48 weeks.). 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 NCT05841654, 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 3 May 2023.