Untreated Essential HypertensionPhase 4NCT01762436
Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension
A Phase 4 study testing bisoprolol and atenolol in people with Untreated Essential Hypertension, run by Ruijin Hospital at 1 site in China.
Trial summary
β-blockers (BBs) with different pharmacological properties may have heterogeneous effects on sympathetic nervous activity (SNA) and central aortic pressure (CAP), which are independent cardiovascular factors for hypertension. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Untreated Essential Hypertension
- What is being tested?
- bisoprolol and atenolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Feb 2012
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25~65 years old
- untreated essential hypertension
- SBP 140-160mmHg \& DBP 90-100mmHg
- Sinus rhythm
- Resting heart rate >70bpm
- Can give written informed consent
Who cannot join
- Atrial Fibrillation (AF)/ Sick Sinus Syndrome (SSS)/ atrioventricular block 2-3 grade(AVBⅡ-Ⅲ) without pacemaker
- Bradyarrhythmia/ hypotensive
- Unstable Angina Pectoris (UAP)/AMI/ HF (NYHA class III - IV)
- Uncontrolled diabetes mellitus (DM)
- Bronchial asthma
- Gastro-intestinal ulcer or skin ulcer
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- Liver dysfunction/ renal impairment
- Treated with CCB (Calcium antagonists) ( except amlodipine) or other beta blocker.
- Glaucoma
- Known allergic/ intolerance to beta blocker
- Pregnant or lactating women
- Participation in another clinical study within the last 3 months
- Legal incapacity or limited legal capacity
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Medical Genomics, Shanghai Key Laboratory of Hypertension and Department of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Randomized Controlled Study: Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension
β-blockers (BBs) with different pharmacological properties may have heterogeneous effects on sympathetic nervous activity (SNA) and central aortic pressure (CAP), which are independent cardiovascular factors for hypertension. Hence, we analyzed the effects of bisoprolol and atenolol on SNA and CAP in hypertensive patients.
- Conditions
- Untreated Essential Hypertension
- Being tested
- bisoprolol, atenolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bisoprololDrug
atenololDrug
| Study group | Role | What they receive |
|---|---|---|
| bisoprolol | Experimental | initially received 5 mg of bisoprolol (Concor®, Merck Serono, Darmstadt, Germany) once daily. The heart rate was assessed every two weeks. If the RHR was ≤65 bpm, a 2-week maintenance treatment was added during the final visit. If the target RHR was not achieved, the dose was changed as recommended in the study protocol. The maximal dose was 10 mg Qd for bisoprolol. The longest treatment period was 8 weeks. If the patient's RHR did not reach below 65 bpm at week 6, the treatment was ended at week 8. Receives: Drug: bisoprolol |
| atenolol | Active comparator | initially received 50 mg atenolol (Beijing Double-Crane Pharmaceutical Co., Ltd, Beijing, China) once daily. The heart rate was assessed every two weeks. If the RHR was ≤65 bpm, a 2-week maintenance treatment was added during the final visit. If the target RHR was not achieved, the dose was changed as recommended in the study protocol. The maximal dose was 100 mg Qd for atenolol. The longest treatment period was 8 weeks. If the patient's RHR did not reach below 65 bpm at week 6, the treatment was ended at week 8. Receives: Drug: atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
baroreflex sensitivity
After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit
Measured: 4~8 weeks
central aortic pressure
After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit
Measured: 4~8 weeks
Secondary outcomes (3)
heart rate variability
After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit
Measured: 4~8 weeks
peripheral blood pressure
After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit
Measured: 4-8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Untreated Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijun Zhou, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762436
- Sponsor's protocol ID
- Betablocker on CAP and BRS
- Status last verified
- Jan 2013
- First submitted
- 4 Jan 2013
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhou WJ, Wang RY, Li Y, Chen DR, Chen EZ, Zhu DL, Gao PJ. A randomized controlled study on the effects of bisoprolol and atenolol on sympathetic nervous activity and central aortic pressure in patients with essential hypertension. PLoS One. 2013 Sep 10;8(9):e72102. doi: 10.1371/journal.pone.0072102. eCollection 2013.
PubMed 24039738
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study: Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01762436
- Acronym / sponsor ID
- Betablocker on CAP and BRS
- Conditions
- Untreated Essential Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Jan 2013 (estimated)
- 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.
β-blockers (BBs) with different pharmacological properties may have heterogeneous effects on sympathetic nervous activity (SNA) and central aortic pressure (CAP), which are independent cardiovascular factors for hypertension. Hence, we analyzed the effects of bisoprolol and atenolol on SNA and CAP in hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bisoprolol | Experimental | Drug: bisoprololinitially received 5 mg of bisoprolol (Concor®, Merck Serono, Darmstadt, Germany) once daily. The heart rate was assessed every two weeks. If the RHR was ≤65 bpm, a 2-week maintenance treatment was added during the final visit. If the target RHR was not achieved, the dose was changed as recommended in the study protocol. The maximal dose was 10 mg Qd for bisoprolol. The longest treatment period was 8 weeks. If the patient's RHR did not reach below 65 bpm at week 6, the treatment was ended at week 8. |
| atenolol | Active comparator | Drug: atenololinitially received 50 mg atenolol (Beijing Double-Crane Pharmaceutical Co., Ltd, Beijing, China) once daily. The heart rate was assessed every two weeks. If the RHR was ≤65 bpm, a 2-week maintenance treatment was added during the final visit. If the target RHR was not achieved, the dose was changed as recommended in the study protocol. The maximal dose was 100 mg Qd for atenolol. The longest treatment period was 8 weeks. If the patient's RHR did not reach below 65 bpm at week 6, the treatment was ended at week 8. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 25~65 years old
- untreated essential hypertension
- SBP 140-160mmHg \& DBP 90-100mmHg
- Sinus rhythm
- Resting heart rate >70bpm
Key exclusion criteria (13 listed)
- Atrial Fibrillation (AF)/ Sick Sinus Syndrome (SSS)/ atrioventricular block 2-3 grade(AVBⅡ-Ⅲ) without pacemaker
- Bradyarrhythmia/ hypotensive
- Unstable Angina Pectoris (UAP)/AMI/ HF (NYHA class III - IV)
- Uncontrolled diabetes mellitus (DM)
- Bronchial asthma
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 |
|---|---|---|
| bisoprolol | Drug | bisoprolol |
| atenolol | Drug | atenolol |
Primary outcome
baroreflex sensitivity
Time frame: 4~8 weeks
After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit
central aortic pressure
Time frame: 4~8 weeks
After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit
3 secondary outcomes
heart rate variability
Time frame: 4~8 weeks
peripheral blood pressure
Time frame: 4-8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 4-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- Derived from this study: PubMed 24039738Zhou WJ, Wang RY, Li Y, Chen DR, Chen EZ, Zhu DL, Gao PJ. A randomized controlled study on the effects of bisoprolol and atenolol on sympathetic nervous activity and central aortic pressure in patients with essential hypertension. PLoS One. 2013 Sep 10;8(9):e72102. doi: 10.1371/journal.pone.0072102. eCollection 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bisoprolol and atenolol in people with Untreated Essential Hypertension, run by Ruijin 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 8 Jan 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
baroreflex sensitivity (time frame: 4~8 weeks). The study lists 2 primary outcomes in all. 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 NCT01762436, which also lists 1 linked publication.
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 8 Jan 2013.