High-normal Blood Pressure
Conditions
Brief summary
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.
Interventions
DRUGTelmisartan
Patients will receive Telmisartan 40 mg, administered as one tablet once daily.
DRUGIndapamide
Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.
OTHERPlacebo
Patients will receive a placebo, administered as half a tablet once daily.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 50-79 years, regardless of sex. 2. Blood Pressure: Systolic blood pressure (SBP) 130 ≤ SBP \< 140 mmHg and/or diastolic blood pressure (DBP) 85 ≤ DBP \< 90 mmHg. 3. Presence of at least one cardiovascular risk factor. 4. Capacity to provide informed consent.
Exclusion criteria
1. Diabetes mellitus (FPG ≥ 7.0 mmol/L and/or OGTT 2h PG ≥ 11.1 mmol/L). 2. Hypertension (SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg) or current use of antihypertensive medication. 3. Participation in another clinical trial within 3 months prior to enrollment or concurrently with this study. 4. Significant renal impairment (serum creatinine ≥ 2.5 mg/dL). 5. Significant hepatic dysfunction (ALT \> 2 × upper limit of normal \[ULN\]). 6. Serum potassium \< 3.5 mmol/L or \> 5.6 mmol/L. 7. Known hypersensitivity to the investigational drugs used in this study. 8. History of stroke or myocardial infarction within 3 months prior to study entry. 9. Undergoing or scheduled for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to study start. 10. Other serious medical conditions (e.g., malignant tumors). 11. Pregnant women or women of childbearing potential who are not using effective contraception or likely to become pregnant. 12. Patients who are bedridden or unable to attend clinic visits. 13. Any other condition requiring antihypertensive medication. 14. Any indication or contraindication for the investigational drug or other antihypertensive agents. 15. Subjects deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization). | through study completion, an average of 4 year | 1. New-onset hypertension Incidence of new-onset hypertension during follow-up. Unit of Measure: Number and percentage of participants. 2. New-onset diabetes Incidence of new-onset diabetes during follow-up. Unit of Measure: Number and percentage of participants. 3. 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. |
Countries
China
Outcome results
None listed