A prospective, randomized, controlled clinical study of enalapril and folic acid tablet in the prevention of contrast induced nephropathy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-17011268

Enrollment

Unknown

Registered

2017-04-30

Start date

2017-06-01

Completion date

Unknown

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contrast induced nephropathy

Interventions

enalapril and folic acid tablets group: treatment with enalapril and folic acid tablets (AUSA Pharmed, Shenzhen), 1 single-pill tablet every day from 2 days before to 3 days after contrast medium admi

control group: the control group did not receive any ACEI/ARBs

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) volunteered to participate in this trial and signed informed consent; (2) Aged 18 to 80 Years; (3) Planned percutaneous coronary intervention(PCI); (4) CKD stages 2, eGFR 60 to 89ml/min per 1.73m2; (5) Without taking folic acid or folic acid-containing preparation, contraceptive, Vitamin B6 and B12, and other drugs affecting metabolism of Hcy in the past month; (6) Without received any ACEI/ARB at least 14 days; (7) If needed to re-select PCI could wait for more than 1 weeks.

Exclusion criteria

Exclusion criteria: (1) Hypersensitivity to iodine-containing compounds and ACEI/ARB; (2) CKD stages 1,3,4 or 5 (eGFR=90ml/min per 1.73m2 or eGFR<60ml/min per 1.73m2); (3) acute ST-segment elevation myocardial infarction (STEMI); (4) NYHA class IV or hemodynamic instability; (5) Administration of ACEI/ARB within 14 days before randomization; (6) Take CT, MRI and other examinations with contrast agents during the two weeks before study; take radiographic examination of other contrast agents during the study period; (7) blood pressure <120/80mmHg; (8) Hepatic dysfunction (ALT 3 times greater than upper normal limit); (9) Thyreoid insufficiency; (10) Malignant tumors, inflammatory diseases, autoimmune diseases.

Design outcomes

Primary

Measure	Time frame
serum creatinine;Primary Outcome Measures:The incedence of CIN;	—

Secondary

Measure	Time frame
Urinary albumin / creatinine ratio;Secondary Outcome Measures: The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes occurring within 30 days after contrast.;	—

Countries

China

Contacts

Public ContactChengchun Tang

Department of Cardiology, Zhongda Hospital of Southeast University Medical School

tangchengchun@medmail.com.cn+86 13914705570

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026