Dilated CardiomyopathyPhase 3NCT00505154
Effect of Rosuvastatin on Left Ventricular Remodeling
A Phase 3 study testing Rosuvastatin in people with Dilated Cardiomyopathy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to examine the the effect of the HMG-CoA reductase inhibitor Rosuvastatin on left ventricular remodeling in patients with dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2007to Jul 2013
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18-80 years
- Have clinical or symptomatic evidence of HF, in NYHA class II-IV, for at least 3 months
- Have LVEF <40%
- On optimal medical treatment and considered unsuitable for surgical intervention.
- Have given written informed consent
- No planned heart transplantation
- Female of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
Who cannot join
- Evidence of unstable disease
- Evidence of ischemic etiology on the basis of history (diagnosed myocardial infarction), echocardiography or angiography)
- Evidence of clinical significant valvular disease based on echocardiography
- Significant concomitant diseases such as infections, pulmonary disease or connective tissue disease.
- Contraindication against statin therapy
- Hypersensitivity against statins
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- Liver disease with SGOT and SGPT > 2 timer upper normal limit
- Baseline elevations of CK 3 times upper normal values at any time during the course of the study
- Serum creatinine above 2.0 mg/dL (177 umol/L) at any time during the course of the study
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure
The purpose of this study is to examine the the effect of the HMG-CoA reductase inhibitor Rosuvastatin on left ventricular remodeling in patients with dilated cardiomyopathy.
Read the detailed description
- Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine.
- Idioatic dilated cardiomyopathy (CMP) represents the final common expression of primary myocardial damage produced by a variety of as yet undefined myocardial insults, producing areas of interstitial and perivascular fibrosis, particularly of the left ventricle. Chronic HF, including CMP, is a progressive disease with high morbidity and mortality, suggesting that important pathogenic mechanisms remain active and unmodified by the present treatment modalities. The presence of chronic inflammation in patients with chronic heart failure has been widely recognized and coupled with persistent immune activation may represent such unmodified mechanisms.
The effect of statin therapy on lipids are well known, but recent studies suggest that the beneficial effects of statins also may be related to their anti-inflammatory properties.
To further elucidate this issue we want to study the potent new statin Rosuvastatin on myocardial function and remodeling and their relation to inflammatory markers in patients with IDCM. As hyperlipidemia is not involved in the pathogenesis of IDCM, as opposed to HF secondary to CAD, such studies will also be an interesting approach in separating the lipid lowering from other effects of these medications in HF.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Rosuvastatin, placebo
- Keywords
- Heart failure, inflammation, cytokines
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Rosuvastatin 10 mg tablets od for 6 months
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Placebo tablets Receives: Drug: placebo |
| 1 | Active comparator | rosuvastatin Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF).
Measured: 2009
Secondary outcomes (1)
the B-type natriuretic peptide (BNP), Effect on immunological variables
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Gullestad, Rikshospitalet University Hospital
- Investigators
- Geir Gokstad, Study director, Rikshospitalet, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505154
- Sponsor's protocol ID
- LG012007
- Status last verified
- Jan 2014
- First submitted
- 20 Jul 2007
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Broch K, Askevold ET, Gjertsen E, Ueland T, Yndestad A, Godang K, Stueflotten W, Andreassen J, Svendsmark R, Smith HJ, Aakhus S, Aukrust P, Gullestad L. The effect of rosuvastatin on inflammation, matrix turnover and left ventricular remodeling in dilated cardiomyopathy: a randomized, controlled trial. PLoS One. 2014 Feb 25;9(2):e89732. doi: 10.1371/journal.pone.0089732. eCollection 2014.
PubMed 24586994
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure
- ClinicalTrials.gov ID
- NCT00505154
- Acronym / sponsor ID
- LG012007
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Heart failure, inflammation, cytokines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Jul 2007 (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.
The purpose of this study is to examine the the effect of the HMG-CoA reductase inhibitor Rosuvastatin on left ventricular remodeling in patients with dilated cardiomyopathy.
Detailed description
- Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine.
- Idioatic dilated cardiomyopathy (CMP) represents the final common expression of primary myocardial damage produced by a variety of as yet undefined myocardial insults, producing areas of interstitial and perivascular fibrosis, particularly of the left ventricle. Chronic HF, including CMP, is a progressive disease with high morbidity and mortality, suggesting that important pathogenic mechanisms remain active and unmodified by the present treatment modalities. The presence of chronic inflammation in patients with chronic heart failure has been widely recognized and coupled with persistent immune activation may represent such unmodified mechanisms.
The effect of statin therapy on lipids are well known, but recent studies suggest that the beneficial effects of statins also may be related to their anti-inflammatory properties.
To further elucidate this issue we want to study the potent new statin Rosuvastatin on myocardial function and remodeling and their relation to inflammatory markers in patients with IDCM. As hyperlipidemia is not involved in the pathogenesis of IDCM, as opposed to HF secondary to CAD, such studies will also be an interesting approach in separating the lipid lowering from other effects of these medications in HF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: placeboPlacebo tablets |
| 1 | Active comparator | Drug: Rosuvastatinrosuvastatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of 18-80 years
- Have clinical or symptomatic evidence of HF, in NYHA class II-IV, for at least 3 months
- Have LVEF <40%
- On optimal medical treatment and considered unsuitable for surgical intervention.
- Have given written informed consent
Key exclusion criteria (10 listed)
- Evidence of unstable disease
- Evidence of ischemic etiology on the basis of history (diagnosed myocardial infarction), echocardiography or angiography)
- Evidence of clinical significant valvular disease based on echocardiography
- Significant concomitant diseases such as infections, pulmonary disease or connective tissue disease.
- Contraindication against statin therapy
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 |
|---|---|---|
| RosuvastatinRosuvastatin 10 mg tablets od for 6 months | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF).
Time frame: 2009
1 secondary outcome
the B-type natriuretic peptide (BNP), Effect on immunological variables
Time frame: 2009
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 27 Jan 2014.
- Derived from this study: PubMed 24586994Broch K, Askevold ET, Gjertsen E, Ueland T, Yndestad A, Godang K, Stueflotten W, Andreassen J, Svendsmark R, Smith HJ, Aakhus S, Aukrust P, Gullestad L. The effect of rosuvastatin on inflammation, matrix turnover and left ventricular remodeling in dilated cardiomyopathy: a randomized, controlled trial. PLoS One. 2014 Feb 25;9(2):e89732. doi: 10.1371/journal.pone.0089732. eCollection 2014.
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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.
Geir Gokstad study director
Rikshospitalet, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin in people with Dilated Cardiomyopathy, run by Oslo University Hospital at 1 site in Norway.
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 7 inclusion and 10 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 27 Jan 2014. 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 Norway. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF). (time frame: 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00505154, which also lists 1 linked publication.
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 27 Jan 2014; AzTrials last refreshed its copy on 6 Nov 2026.