The POSITIVE (Pre-Operative STatin InterVEntion) study, preoperative statin intervention for valve surgery.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27097

Enrollment

Registered

2011-01-03

Start date

2011-01-15

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Cardiac surgery, postoperative inflammation

Interventions

After giving informed consent patients will be randomized into: 1. Acute treatment: One dose of 40 mg simvastatin the evening before and one dose of 40 mg simvastatine the morning before surgery

2. Long term treatment: 40 mg simvastatine for a minimum of 2 weeks prior to surgery.

Eligibility

Inclusion criteria

Inclusion criteria: Acceptation for mitral/tricuspid valve surgery via sternotomy.

Exclusion criteria

Exclusion criteria: 1. Statine use; 2. Acceptation for minimal invasive surgery; 3. Ablation or CABG procedures; 4. Emergency operations; 5. Clinically diagnosed heart failure or atherosclerosis; 6. Use of corticosteroids.

Design outcomes

Primary

Measure	Time frame
1. Inflammatory response (IL-6, CRP); 2. Myocardial damage (troponin); 3. Pathophysiology of ischemia/reperfusion injury.	—

Contacts

Public ContactJan H. Lindeman

Leiden University Medical Center Dpt. of Vascular Surgery. PO-box 9600

Lindeman@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)