Heart FailurePhase 2NCT00176332
Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure
A Phase 2 study testing rosuvastatin in people with Heart Failure, run by University of Leipzig at 1 site in Germany.
Trial summary
Statin therapy has been shown to efficiently reduce mortality in patients with coronary artery disease and myocardial infarction, partially as a result of the lipid-lowering properties of statins. However, especially the pleiotropic effects of statins, e.g. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- rosuvastatin
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2004to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic heart failure (NYHA class III or IV)
- peak oxygen uptake <20 mL/min/kg body weight
- left ventricular ejection fraction <30 %
- left ventricular end-diastolic diameter >55 mm
- stable medication within the last 4 weeks
Who cannot join
- elevated GOT and GPT levels as a sign of hepatic dysfunction
- elevated creatinine levels as a sign of renal dysfunction
- insulin-dependent diabetes mellitus
- arterial hypertension
- muscle disease or elevated CK levels
- treatment with fibrates
- co-treatment with drugs that are metabolized by Cyp3A4
- diseases that disallow a participation in the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
Leipzig, Saxony, 04289
About this study
Official title: Impact of Three Months of Rosuvastatin Treatment on Peripheral Endothelial Function, Inflammatory Markers in the Blood and the Skeletal Muscle and on Postnatal Vasculogenesis in Patients With Severe Chronic Heart Failure
Statin therapy has been shown to efficiently reduce mortality in patients with coronary artery disease and myocardial infarction, partially as a result of the lipid-lowering properties of statins. However, especially the pleiotropic effects of statins, e.g. their anti-inflammatory and anti-oxidative properties, might be of interest in the treatment of patients with chronic heart failure that are limited in their exercise capacity due to alterations of the skeletal muscle and peripheral endothelial dysfunction.
Aim of this trial is therefore to assess the effects of three months of rosuvastatin treatment on markers of inflammation and oxidative stress in the skeletal muscle and the blood, on postnatal vasculogenesis, and endothelial function of the radial artery in patients with severe chronic heart failure.
Read the detailed description
A total of 40 patients with severe chronic heart failure are prospectively randomized to either 3 months of rosuvastatin or placebo treatment.
Before and after the intervention period maximal exercise capacity is measured by ergospirometry and endothelial function is determined by high-resolution A-mode ultrasound. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for inflammatory markers, measures of oxidative stress and vasculogenesis. Blood samples are assessed with regard to markers of inflammation and oxidative stress as well.
- Conditions
- Heart Failure
- Being tested
- rosuvastatin
- Keywords
- chronic heart failure, rosuvastatin, endothelial function, skeletal muscle
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation in the blood and the skeletal muscle
Vasculogenesis
Endothelial function of the radial artery
Secondary outcomes (2)
Peak oxygen uptake
Left ventricular function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Rainer P Hambrecht, MD, Principal investigator, University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176332
- Sponsor's protocol ID
- 121/2003
- Status last verified
- Jul 2007
- First submitted
- 10 Sep 2005
- Last updated
- 1 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Three Months of Rosuvastatin Treatment on Peripheral Endothelial Function, Inflammatory Markers in the Blood and the Skeletal Muscle and on Postnatal Vasculogenesis in Patients With Severe Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00176332
- Acronym / sponsor ID
- 121/2003
- Conditions
- Heart Failure
- Keywords
- chronic heart failure, rosuvastatin, endothelial function, skeletal muscle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Statin therapy has been shown to efficiently reduce mortality in patients with coronary artery disease and myocardial infarction, partially as a result of the lipid-lowering properties of statins. However, especially the pleiotropic effects of statins, e.g. their anti-inflammatory and anti-oxidative properties, might be of interest in the treatment of patients with chronic heart failure that are limited in their exercise capacity due to alterations of the skeletal muscle and peripheral endothelial dysfunction.
Aim of this trial is therefore to assess the effects of three months of rosuvastatin treatment on markers of inflammation and oxidative stress in the skeletal muscle and the blood, on postnatal vasculogenesis, and endothelial function of the radial artery in patients with severe chronic heart failure.
Detailed description
A total of 40 patients with severe chronic heart failure are prospectively randomized to either 3 months of rosuvastatin or placebo treatment.
Before and after the intervention period maximal exercise capacity is measured by ergospirometry and endothelial function is determined by high-resolution A-mode ultrasound. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for inflammatory markers, measures of oxidative stress and vasculogenesis. Blood samples are assessed with regard to markers of inflammation and oxidative stress as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic heart failure (NYHA class III or IV)
- peak oxygen uptake <20 mL/min/kg body weight
- left ventricular ejection fraction <30 %
- left ventricular end-diastolic diameter >55 mm
- stable medication within the last 4 weeks
Key exclusion criteria (8 listed)
- elevated GOT and GPT levels as a sign of hepatic dysfunction
- elevated creatinine levels as a sign of renal dysfunction
- insulin-dependent diabetes mellitus
- arterial hypertension
- muscle disease or elevated CK levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosuvastatin | Drug | – |
Primary outcome
Inflammation in the blood and the skeletal muscle
Vasculogenesis
Endothelial function of the radial artery
2 secondary outcomes
Peak oxygen uptake
Left ventricular function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer P Hambrecht, MD principal investigator
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rosuvastatin in people with Heart Failure, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation in the blood and the skeletal muscle. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2007.