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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Shandong
-
Jinan, Shandong, Kina, 250000
- Qilu Hospital of Shandong University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
Patients will receive a placebo, administered as half a tablet once daily.
|
Patients will receive a placebo, administered as half a tablet once daily.
|
|
Experimentell: Telmisartan
Patients will receive Telmisartan 40 mg, administered as one tablet once daily.
|
Patients will receive Telmisartan 40 mg, administered as one tablet once daily.
|
|
Experimentell: Indapamide
Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.
|
Patients will receive Indapamide 1.5 mg, administered as one capsule every other day.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).
Tidsram: through study completion, an average of 4 year
|
Unit of Measure: Number and percentage of participants. |
through study completion, an average of 4 year
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.
Tidsram: through study completion, an average of 4 year
|
through study completion, an average of 4 year
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2006BAI01A03
Läkemedels- och apparatinformation, studiedokument
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