HypertensionPhase 4NCT02817503

Feasibility Study of the Intensive Systolic Blood Pressure Control

A Phase 4 study of Hypertension and Hyperhomocysteinemia, run by Second Affiliated Hospital of Nanchang 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Who is it for?: Ages 60 years and older
Conditions the study is for: Hypertension, Hyperhomocysteinemia
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: Dec 2015to Dec 2016
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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hypertensive patients aged 60 years or older.
SBP>= 150 mmHg but <180 mmHg, if currently (within the previous two weeks) not regularly treated with antihypertensive drugs.
If currently (at least 10 days on medications within the previous two weeks) regularly treated with antihypertensive drugs, blood pressure must meet the following criteria:
SBP >= 140 mmHg but <170 mmHg, if regularly (no less than 10 days) taking 1 type of antihypertensive medication within the previous two weeks; SBP >= 130 mmHg but <160 mmHg, if regularly (no less than 10 days) taking 2 types of antihypertensive medications within the previous two weeks; SBP >= 130 mmHg but <150 mmHg, if regularly (no less than 10 days) taking 3 types of antihypertensive medication within the previous two weeks.
For patients taking a fixed-dose-combination (FDC), this treatment will be considered as two types of drugs if the dose of each component of the FDC is equal to higher than the routine therapeutic dose.
Blood homocysteine (Hcy)≥ 10μmol/L, or the patient is taking enalapril-folic acid;
Subject has read and signed a written, informed consent form.

Who cannot join

History of physician diagnosed stroke, myocardial infarction, heart failure, revascularization, or malignancy;
Clearly diagnosed secondary hypertension;
Undergoing regular renal dialysis or has been diagnosed with end-stage kidney disease;
Congenital or acquired organic heart disease;
Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating;
Contraindicated or intolerable to ACEIs (including enalapril-folic acid) or a history of severe adverse effects to ACEIs;

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Individuals with abnormal laboratory test results and/or clinical manifestations rendering them unsuitable to participate as judged by the investigators;
Any factor likely to limit adherence to interventions or jeopardize data collection, for example: dementia, severe mental disorders impeding expression or communication abilities, an inability to adhere the follow-up plan, plans to move in the near future, or, a history of unreliability in following a medication regimen or in keeping appointments;
Living with a family member (a spouse, for example) who has already participated in the study;
Unwilling to participate, unwilling or unable to change current therapeutic regimen;
Currently (or within one month) participating in another new drug trial.

Trial locations and contacts

1 site in 1 country.

China1 site

the People's Hospital of Rongcheng
Yatou, Shandong, 264300

Other trials in China

About this study

Official title: Effects of Intensive Antihypertensive Therapies on the Risk of Stroke in Hypertensive Adults: A Prospective Randomized Open-Label Blinded-Endpoint Trial, a Feasibility Study

The purpose of the current feasibility study is to test whether the blood pressure level of the study patients can be effectively and safely managed according to the intensive antihypertensive treatment protocol. Furthermore, the study will also examine the effect of intensive antihypertensive treatment on the intermediate cardiovascular diseases outcomes, including CIMT, carotid plaques, PWV ABI, and kidney function, etc.

Read the detailed description

The China Stroke Primary Prevention Trial (CSPPT, NCT00794885) found that among hypertensive adults in China without a history of stroke or myocardial infarction, the combined use of enalapril and folic acid, compared with enalapril alone, significantly reduced the risk of first stroke. The mean systolic blood pressures were highly comparable between the two groups over the course of the trial (139.7mmHg and 139.8mmHg, respectively, in the enalapril-folic acid and the enalapril group). In the further analysis, lower systolic blood pressures seemed to be associated with greater reduction in cardiovascular outcomes in both of the treatment groups.

However, due to inconsistencies in the results of the ACCORD and SPRINT trials, the appropriate targets for systolic blood pressure in effectively reducing cardiovascular events among hypertensive patients remain uncertain.

The proposed trial aims to test the hypothesis that among hypertensive patients aged 60 years or older, a lower systolic blood pressure goal will lead to greater reduction in stroke incidence.

The current feasibility study aims to test whether the blood pressure level of the study patients can be effectively and safely managed according to the intensive antihypertensive treatment protocol. Furthermore, the study will also examine the effect of intensive antihypertensive treatment on the intermediate cardiovascular diseases outcomes, including CIMT, carotid plaques, PWV ABI, and kidney function, etc.

The current feasibility study will enroll approximately 100 patients with H-type hypertension (hypertensive patients with hyperhomocysteinemia) aged 60 years or older, and without a history of major cardiovascular diseases.

Eligible patients will randomly assigned to one of three different systolic blood pressure (SBP) target groups (Group A, SBP: 140 - <150 mmHg; Group B, SBP: 130 - < 140 mmHg; and Group C, SBP < 130 mmHg).

Conditions: Hypertension, Hyperhomocysteinemia
Being tested: Standard BP control, Moderate BP control, Intensive BP control
Keywords: hypertension, BP titration, intensive blood pressure control, primary prevention, China, H-type Hypertension
Medical subject headings: Hypertension, Hyperhomocysteinemia

What participants receive

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

Standard BP controlDrug
Also called Enalapril-folic acid,amlodipine,hydrochlorothiazide
Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.
Moderate BP controlDrug
Also called Enalapril-folic acid,amlodipine,hydrochlorothiazide
Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.
Intensive BP controlDrug
Also called Enalapril-folic acid,amlodipine,hydrochlorothiazide
Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.

Study groups in NCT02817503
Study group	Role	What they receive
Standard BP control	Experimental	SBP within 140 - <150 mmHg. For all participants, enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol. Receives: Drug: Standard BP control
Moderate BP control	Active comparator	SBP within 130 - <140 mmHg. For all participants, enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol. Receives: Drug: Moderate BP control
Intensive BP control	Active comparator	SBP <130 mmHg. For all participants, enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol. Receives: Drug: Intensive BP control

What is being measured

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

Achieved mean blood pressure levels in each of the treatment groups
Measured: 6 months BP titration treatment period

Secondary outcomes (4)

Carotid intima-media thickness (CIMT), Carotid plaques
Measured: 6 months BP titration treatment period
Carotid-femoral pulse wave velocity, Brachial-ankle pulse wave velocity
Measured: 6 months BP titration treatment period
Ankle brachial index
Measured: 6 months BP titration treatment period
Urinary albumin-creatinine ratio
Measured: 6 months BP titration treatment period

Timeline

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

Dec 2015Dec 2016

First posted29 Jun 2016 (estimated)
Study startDec 2015
Primary completionDec 2016 (estimated)
Study completionDec 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Second Affiliated Hospital of Nanchang UniversityThe 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02817503
Sponsor's protocol ID: 20151BDH80038
Status last verified: Oct 2016
First submitted: 18 Jun 2016
Last updated: 14 Oct 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF; CSPPT Investigators. Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1325-35. doi: 10.1001/jama.2015.2274.
PubMed 25771069
Huang X, Liu L, Song Y, Gao L, Zhao M, Bao H, Qin X, Wu Y, Wu Q, Bi C, Yue A, Fang C, Ma H, Cui Y, Tang G, Li P, Zhang Y, Li J, Wang B, Xu X, Wang H, Parati G, Spence JD, Wang X, Huo Y, Chen G, Cheng X; investigators of intensive BP control in China. Achieving blood pressure control targets in hypertensive patients of rural China - a pilot randomized trial. Trials. 2020 Jun 11;21(1):515. doi: 10.1186/s13063-020-04368-1.
PubMed 32527283

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Intensive Antihypertensive Therapies on the Risk of Stroke in Hypertensive Adults: A Prospective Randomized Open-Label Blinded-Endpoint Trial, a Feasibility Study
ClinicalTrials.gov ID: NCT02817503
Acronym / sponsor ID: 20151BDH80038
Conditions: Hypertension, Hyperhomocysteinemia
Keywords: hypertension, BP titration, intensive blood pressure control, primary prevention, China, H-type Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
Collaborators: Peking University First Hospital
Study start: Dec 2015
Primary completion: Dec 2016 (estimated)
Study completion: Dec 2016 (estimated)
First posted: 29 Jun 2016 (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.

Detailed description

The proposed trial aims to test the hypothesis that among hypertensive patients aged 60 years or older, a lower systolic blood pressure goal will lead to greater reduction in stroke incidence.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Standard BP control	Experimental	Drug: Standard BP controlSBP within 140 - <150 mmHg. For all participants, enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
Moderate BP control	Active comparator	Drug: Moderate BP controlSBP within 130 - <140 mmHg. For all participants, enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
Intensive BP control	Active comparator	Drug: Intensive BP controlSBP <130 mmHg. For all participants, enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices. If the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Hypertensive patients aged 60 years or older.
SBP>= 150 mmHg but <180 mmHg, if currently (within the previous two weeks) not regularly treated with antihypertensive drugs.
If currently (at least 10 days on medications within the previous two weeks) regularly treated with antihypertensive drugs, blood pressure must meet the following criteria:
SBP >= 140 mmHg but <170 mmHg, if regularly (no less than 10 days) taking 1 type of antihypertensive medication within the previous two weeks; SBP >= 130 mmHg but <160 mmHg, if regularly (no less than 10 days) taking 2 types of antihypertensive medications within the previous two weeks; SBP >= 130 mmHg but <150 mmHg, if regularly (no less than 10 days) taking 3 types of antihypertensive medication within the previous two weeks.
For patients taking a fixed-dose-combination (FDC), this treatment will be considered as two types of drugs if the dose of each component of the FDC is equal to higher than the routine therapeutic dose.

Key exclusion criteria (11 listed)

History of physician diagnosed stroke, myocardial infarction, heart failure, revascularization, or malignancy;
Clearly diagnosed secondary hypertension;
Undergoing regular renal dialysis or has been diagnosed with end-stage kidney disease;
Congenital or acquired organic heart disease;
Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating;

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
Standard BP controlAlso: Enalapril-folic acid,amlodipine,hydrochlorothiazideEnalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.	Drug	Standard BP control
Moderate BP controlAlso: Enalapril-folic acid,amlodipine,hydrochlorothiazideEnalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.	Drug	Moderate BP control
Intensive BP controlAlso: Enalapril-folic acid,amlodipine,hydrochlorothiazideEnalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.	Drug	Intensive BP control

Primary outcome

Achieved mean blood pressure levels in each of the treatment groups
Time frame: 6 months BP titration treatment period

4 secondary outcomes

Carotid intima-media thickness (CIMT), Carotid plaques
Time frame: 6 months BP titration treatment period
Carotid-femoral pulse wave velocity, Brachial-ankle pulse wave velocity
Time frame: 6 months BP titration treatment period
Ankle brachial index
Time frame: 6 months BP titration treatment period
Urinary albumin-creatinine ratio
Time frame: 6 months BP titration treatment period

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
Background: PubMed 25771069Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF; CSPPT Investigators. Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1325-35. doi: 10.1001/jama.2015.2274.
Derived from this study: PubMed 32527283Huang X, Liu L, Song Y, Gao L, Zhao M, Bao H, Qin X, Wu Y, Wu Q, Bi C, Yue A, Fang C, Ma H, Cui Y, Tang G, Li P, Zhang Y, Li J, Wang B, Xu X, Wang H, Parati G, Spence JD, Wang X, Huo Y, Chen G, Cheng X; investigators of intensive BP control in China. Achieving blood pressure control targets in hypertensive patients of rural China - a pilot randomized trial. Trials. 2020 Jun 11;21(1):515. doi: 10.1186/s13063-020-04368-1.
Individual participant dataSharing planned: No

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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.

Xiaoshu Cheng, MD principal investigator

Second Affiliated Hospital of Nanchang University

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 of Hypertension and Hyperhomocysteinemia, run by Second Affiliated Hospital of Nanchang 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 7 inclusion and 11 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 14 Oct 2016. 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?

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?

Achieved mean blood pressure levels in each of the treatment groups (time frame: 6 months BP titration treatment period). 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 NCT02817503, which also lists 2 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 14 Oct 2016.