CSPPT- Chronic Kidney Diseases Study
Słowa kluczowe
Abstrakcyjny
Opis
Elevated blood concentration of homocysteine (Hcy) has been suggested as a modifiable, independent risk factor for coronary artery disease, stroke, and deep vein thrombosis. Prevalence of hyperhomocysteinemia and folic acid deficiency in China are significantly higher than those in Europe and USA. The investigators' preliminary research demonstrated that blood concentration of Hcy was negatively correlated to estimated glomerular filtration rate (eGFR), a key index of kidney function. However, the question as to whether Hcy-lowering therapy with folic acid can reduce the risk of chronic kidney disease(CKD) remains to be answered.
This study, exploiting the hypertensive population of CSPPT trial (ClinicalTrials.gov register number: NCT00794885), is intended to compare the effects of enalapril maleate and folic acid tablets versus enalapril maleate in preventing renal function decline among the patients with primary hypertension. The results from this trial may have the potential to transform current clinical and public health findings into practice in the prevention of chronic kidney disease(CKD) in China.
Daktyle
| Ostatnia weryfikacja: | 12/31/2015 |
| Pierwsze przesłane: | 05/28/2013 |
| Szacowana liczba przesłanych rejestracji: | 06/05/2013 |
| Wysłany pierwszy: | 06/06/2013 |
| Ostatnia aktualizacja przesłana: | 01/17/2016 |
| Ostatnia opublikowana aktualizacja: | 01/19/2016 |
| Rzeczywista data rozpoczęcia badania: | 04/30/2008 |
| Szacowana data zakończenia podstawowej działalności: | 05/31/2014 |
| Szacowana data zakończenia badania: | 07/31/2014 |
Stan lub choroba
Interwencja / leczenie
Drug: Enalapril maleate and folic acid tablets
Drug: Enalapril maleate
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Experimental: Enalapril maleate and folic acid tablets A fixed combination drug is given. The dose is fixed in enalapril 10 mg / folic acid 0.8 mg per day. | Drug: Enalapril maleate and folic acid tablets Enalapril maleate and folic acid tablets, (10mg/0.8mg)/tablet, taken orally and once daily for a maximum of 5 years. Combination with other anti-hypertension drugs are allowed. |
| Active Comparator: Enalapril maleate Enalapril maleate 10 mg per day is given | Drug: Enalapril maleate Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed. |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 45 Years Do 45 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - BP≥140/90 mmHg in both of the two screening visits or currently under anti-hypertension treatment; - 45-75 years old; - Successful determination of methylenetetrahydrofolate reductase (MTHFR) C677T genotype; - For pre-menopausal women, agreed to use contraceptives during the trial; - Signed the written informed consent. Exclusion Criteria: - Having a history of stroke; - Having a history of myocardial infarction; - Having a history of physician diagnosed heart failure; - Post- coronary revascularization; - Severe somatic disease such as cancer; - Secondary hypertension; - Congenital or acquired organic heart diseases; - Contraindicated to angiotensin-converting enzyme inhibitor (ACEI); - Having a history of ACEI adverse effects; - Currently long-term use of folic acid or vitamin B12 or vitamin B6; - Pregnant or child breastfeeding women; - Severe mental disorders; - Lab tests indicating abnormal liver or kidney function; - Unwilling to participate the trial; - Unwilling to change the current antihypertensive treatment. |
Wynik
Podstawowe miary wyników
1. Renal function decline [Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.]
Miary wyników wtórnych
1. Average decline rate in eGFR (ml/min/1.73m2/yr). [Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.]
2. New-onset chronic kidney disease based on eGFR（eGFR<60 ml/min/1.73 m2） [Serum creatinine was examined at baseline and at the final visit (5 years) of the trial.]
3. New-onset albuminuria [Albuminuria was examined at baseline and at the final visit (5 years) of the trial.]
4. A composite of renal events. [Every 3 months during the trial, up to 5 years]
