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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Shandong
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Jinan, Shandong, Chine, 250000
- Qilu Hospital of Shandong University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).
Délai: through study completion, an average of 4 year
|
Unit of Measure: Number and percentage of participants. |
through study completion, an average of 4 year
|
Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
|
Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.
Délai: through study completion, an average of 4 year
|
through study completion, an average of 4 year
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Composés de soufre
- Produits chimiques organiques
- Composés hétérocycliques
- Benzimidazoles
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Hydrocarbures
- Hydrocarbures, cyclique
- Hydrocarbures, aromatique
- Amides
- Indoles
- Dérivés de benzène
- Sulfonamides
- Sulfones
- Composés biphényles
- Telmisartan
- Indapamide
Autres numéros d'identification d'étude
- 2006BAI01A03
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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