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Status unknownNCT02817503Updated Oct 14, 2016

Feasibility Study of the Intensive Systolic Blood Pressure Control

A Phase 4 interventional study of Standard BP control and Moderate BP control in Hypertension and Hyperhomocysteinemia, sponsored by Second Affiliated Hospital of Nanchang University. Status unknown at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-10-14.

Sponsored by Second Affiliated Hospital of Nanchang University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Hypertension
  • Hyperhomocysteinemia

Keywords

  • hypertension
  • BP titration
  • intensive blood pressure control
  • primary prevention
  • China
  • H-type Hypertension
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Second Affiliated Hospital of Nanchang University is the lead sponsor of 85 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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, form.

Exclusion criteria

Exclusion Criteria:

  • History of physician diagnosed stroke, myocardial infarction, heart failure, revascularization, or ;
  • 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;
  • or intolerable to ACEIs (including enalapril-folic acid) or a history of severe adverse effects to ACEIs;
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Standard BP control

    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.

    Drug: Standard BP control

  • Active comparator
    Moderate BP control

    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.

    Drug: Moderate BP control

  • Active comparator
    Intensive BP control

    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.

    Drug: Intensive BP control

Interventions

  • DrugStandard BP control

    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.

    Also known as: Enalapril-folic acid,amlodipine,hydrochlorothiazide

  • DrugModerate BP control

    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.

    Also known as: Enalapril-folic acid,amlodipine,hydrochlorothiazide

  • DrugIntensive BP control

    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.

    Also known as: Enalapril-folic acid,amlodipine,hydrochlorothiazide

06

What researchers measure

Primary outcomes

  1. Achieved mean blood pressure levels in each of the treatment groups

    Time frame: 6 months BP titration treatment period

Secondary outcomes

  1. Carotid intima-media thickness (CIMT), Carotid plaques

    Time frame: 6 months BP titration treatment period

  2. Carotid-femoral pulse wave velocity, Brachial-ankle pulse wave velocity

    Time frame: 6 months BP titration treatment period

  3. Ankle brachial index

    Time frame: 6 months BP titration treatment period

  4. Urinary albumin-creatinine ratio

    Time frame: 6 months BP titration treatment period

Other outcomes

  1. Events related to the intensive blood pressure control, Hypotension, Syncope, Bradycardia or Arrhythmia, Hyperkalemia, Renal Failure

    Time frame: 6 months BP titration treatment period

  2. First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death hospitalization; Hospitalization

    6 months BP titration treatment period

    Time frame: during the Randomization and Titration Treatment period

07

Study locations

1 site
  • the People's Hospital of Rongcheng
    Rongcheng, Shandong 264300, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2015, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2016
First posted
Jun 29, 2016
Start
Dec 2015
Primary completionEst.
Dec 2016
CompletionEst.
Dec 2016
Last update
Oct 14, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02817503
Lead sponsor
Second Affiliated Hospital of Nanchang University
Collaborators
Peking University First Hospital
Responsible party
Xiaoshu Cheng (Professor, Second Affiliated Hospital of Nanchang University) — Principal investigator
First posted
Jun 29, 2016
Start date
Dec 2015
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Oct 14, 2016

Study contacts

Xiaoshu Cheng, MD
principal investigator · Second Affiliated Hospital of Nanchang University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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