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Completed

NCT Number: NCT07652567

Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population

I. Research Objectives

Primary Objectives:

To evaluate the effect of low-dose antihypertensive therapy on the incidence of new-onset hypertension and new-onset diabetes in individuals with high-normal blood pressure and cardiovascular risk factors.

To assess the impact of low-dose antihypertensive therapy on composite cardiovascular events in individuals with high-normal blood pressure and cardiovascular risk factors.

Secondary Objective:

To evaluate the effects of low-dose antihypertensive therapy and different drug regimens on intermediate markers or subclinical status of cardiovascular disease risk, including lipid profiles, carotid atherosclerosis, and arterial stiffness (pulse wave velocity).

II. Study Population Individuals with high-normal blood pressure and comorbid cardiovascular risk factors who have not been treated with antihypertensive medications.

III. Endpoints

Primary Endpoints:

New-onset hypertension and new-onset diabetes. Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).

Other Endpoints:

Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.

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Key information

Conditions

High-normal Blood Pressure

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 50-79 years, regardless of sex.
  • Blood Pressure: Systolic blood pressure (SBP) 130 ≤ SBP < 140 mmHg and/or diastolic blood pressure (DBP) 85 ≤ DBP < 90 mmHg.
  • Presence of at least one cardiovascular risk factor.
  • Capacity to provide informed consent.

Exclusion criteria

  • Diabetes mellitus (FPG ≥ 7.0 mmol/L and/or OGTT 2h PG ≥ 11.1 mmol/L).
  • Hypertension (SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg) or current use of antihypertensive medication.
  • Participation in another clinical trial within 3 months prior to enrollment or concurrently with this study.
  • Significant renal impairment (serum creatinine ≥ 2.5 mg/dL).
  • Significant hepatic dysfunction (ALT > 2 × upper limit of normal [ULN]).
  • Serum potassium < 3.5 mmol/L or > 5.6 mmol/L.
  • Known hypersensitivity to the investigational drugs used in this study.
  • History of stroke or myocardial infarction within 3 months prior to study entry.
  • Undergoing or scheduled for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to study start.
  • Other serious medical conditions (e.g., malignant tumors).
  • Pregnant women or women of childbearing potential who are not using effective contraception or likely to become pregnant.
  • Patients who are bedridden or unable to attend clinic visits.
  • Any other condition requiring antihypertensive medication.
  • Any indication or contraindication for the investigational drug or other antihypertensive agents.
  • Subjects deemed unsuitable for inclusion by the investigator.

Treatment and study plan

Telmisartan

Drug

Patients will receive Telmisartan 40 mg, administered as one tablet once daily.

Indapamide

Drug

Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.

Placebo

Other

Patients will receive a placebo, administered as half a tablet once daily.

Primary outcomes

  1. 1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).

    Time frame: through study completion, an average of 4 year

    • New-onset hypertension Incidence of new-onset hypertension during follow-up. Unit of Measure: Number and percentage of participants.
    • New-onset diabetes Incidence of new-onset diabetes during follow-up. Unit of Measure: Number and percentage of participants.
    • Composite cardiovascular events Incidence of composite cardiovascular events during follow-up, defined as the occurrence of at least one of the following: fatal or non-fatal stroke, myocardial infarction, cardiovascular death, or coronary revascularization. Participants with multiple events will be counted once for the composite endpoint.

    Unit of Measure: Number and percentage of participants.

Other outcomes

  1. Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.

    Time frame: through study completion, an average of 4 year

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2007
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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