Feasibility Study of the Intensive Systolic Blood Pressure Control

NCT02817503 | Unknown Phase 4

• 1 other identifier: 20151BDH80038
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Hyperhomocysteinemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Achieved mean blood pressure levels in each of the treatment groups

  6 months BP titration treatment period

Secondary Outcomes (4)

• Carotid intima-media thickness (CIMT), Carotid plaques

  6 months BP titration treatment period

• Carotid-femoral pulse wave velocity, Brachial-ankle pulse wave velocity

  6 months BP titration treatment period

• Ankle brachial index

  6 months BP titration treatment period

• Urinary albumin-creatinine ratio

  6 months BP titration treatment period

Other Outcomes (2)

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

  6 months BP titration treatment period

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

  during the Randomization and Titration Treatment period

Study Arms (3)

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.

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.

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.

Drug: Intensive BP control

Interventions

Standard BP control DRUG

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

Standard BP control

Moderate BP control DRUG

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

Moderate BP control

Intensive BP control DRUG

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

Intensive BP control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead
• Peking University First Hospital: collaborator

Study Sites (1)

the People's Hospital of Rongcheng

Yatou, Shandong, 264300, China

Location

Related Publications (2)

• 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.

  PMID: 25771069 BACKGROUND

• 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.

  PMID: 32527283 DERIVED

MeSH Terms

Conditions

Hypertension; Hyperhomocysteinemia

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xiaoshu Cheng, MD

  Second Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2016
• First Posted: June 29, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)