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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Shandong
-
Jinan, Shandong, Cina, 250000
- Qilu Hospital of Shandong University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
1.New-onset hypertension and new-onset diabetes. 2.Composite cardiovascular events (fatal and non-fatal stroke, myocardial infarction, cardiovascular death, and coronary revascularization).
Lasso di tempo: through study completion, an average of 4 year
|
Unit of Measure: Number and percentage of participants. |
through study completion, an average of 4 year
|
Altre misure di risultato
Misura del risultato |
Lasso di tempo |
|---|---|
|
Hospitalization for transient ischemic attack (TIA), hospitalization for angina pectoris, hospitalization for heart failure, peripheral vascular disease, malignancy, all-cause mortality, and renal failure.
Lasso di tempo: through study completion, an average of 4 year
|
through study completion, an average of 4 year
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2006BAI01A03
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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