Dutch Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA). PET Sub Study

Heart Failure Clinical Trial

Official title:

Sub Study: Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) PET Sub Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228514
• Other study ID #: 4522IL/0098 Dutch SubStudy
• Secondary ID: D3562C00098
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: November 11, 2010
• Start date: February 2004
• Est. completion date: July 2007

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

At one site, patients participating in the Corona main study are asked to participate in the PET-substudy. Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed to study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients fulfilling the in and exclusion criteria of the CORONA study and separate informed consent for participation in the sub study.

Exclusion Criteria:

• See above

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Positron Emission Tomography (PET)
• Rosuvastatin

Intervention

Drug:
• Rosuvastatin

Procedure:
• Positron emission tomography

Locations

Country	Name	City	State
Netherlands	Research Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the effect of rosuvastatin in Chronic Heart Failure on myocardial perfusion (reserve). Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.
Secondary	To study the effect of rosuvastatin in Chronic Heart Failure on mismatch. Before and 6 months after study medication is started a Positron Emission Tomography (PET-scan) is performed.