Effect of Angiotensin Converting Enzyme Inhibition (ACEI) on C-Reactive Protein (CRP) Levels: The Ramipril CRP Randomized Evaluation (4R Trial)

Completed

• Conditions: Healthy volunteers with elevated levels of C-Reactive protein; Circulatory System

• Registration Number: ISRCTN31129526
• Lead Sponsor: Sanofi-Aventis (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

35-80 years of age, male or female, free of cardiovascular disease, and baseline CRP greater than 2 mg/l

Exclusion Criteria

1. Structural heart disease or vascular disease
2. Systolic blood pressure greater than 160 or less than 100 mmHg
3. Renal or hepatic dysfunction
4. White blood cell (WBC) count greater than 12,000
5. Chronic inflammatory disease
6. Human Immunodeficiency Virus (HIV)
7. Known sensitivity to ACEI
8. Steroid use
9. Chronic (more than 2 weeks) use of non-steroidal anti-inflammatory drugs (NSAIDs)
10. Treatment with:
a. ACEI or Angiotensin II Receptor Blockers (ARB)
b. Lipid lowering agents
c. Hormone replacement therapy
d. Oral hypoglycemic agents
e. Aspirin
f. Antioxidants
11. Failure to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in CRP levels in Ramipril versus placebo arms

Secondary Outcome Measures

Name	Time	Method
Change in endothelial function assessed by pulse wave tomography (photoacoustic tomography [PAT])