Dilated CardiomyopathyNCT01015144
The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle
An observational study of Dilated Cardiomyopathy, run by Medical University of Lodz.
Trial summary
The aim of the study was to assess of the influence of atorvastatin on selected indicators of an inflammatory condition, function of the left ventricle and factors affecting the occurrence of undesired events like rehospitalizations and mortality in patients with dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Tulip
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2007to Feb 2009
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dilated cardiomyopathy (according ESC 2007) with EF≤40% as documented by echocardiography were included.
Who may be able to join
- patients 18 years old or older
- patients who signed informed consent
- patients with dilated cardiomyopathy (according ESC 2007)
- patients who had no significant coronary artery stenoses >30% on cardiac catheterization
Who cannot join
- BP ≥140/90 lub <90/60
- congenital heart disease
- acquired valvular disease except for mitral incompetence secondary to left ventricular dilatation
- New York Heart Association (NYHA) functional class IV
- statin treatment
- preserved hyperactivity of aminotransferases with unexplained etiology,
Show all 19Show fewer
- muscle disorders which might cause drug-induced myopathy,
- uncontrolled diabetes,
- liver diseases,
- creatinine level > 2 mg/dl and/or GFR<30ml/min,
- abuse of alcohol or drugs,
- chronic inflammatory diseases,
- pregnancy or lactation,
- severe hypothyroidism,
- immunosuppressive treatment,
- operation or severe injury during last month
- vaccination during last 3 months
- heart stimulation device or implantable cardioverter defibrillator
- or who didn't write conscious consent
About this study
Official title: The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle in Patients With Dilated Cardiomyopathy
The aim of the study was to assess of the influence of atorvastatin on selected indicators of an inflammatory condition, function of the left ventricle and factors affecting the occurrence of undesired events like rehospitalizations and mortality in patients with dilated cardiomyopathy.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Tulip
- Keywords
- atorvastatin, dilated cardiomyopathy, heart failure, inflammation
- 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.
TulipDrug
Patients were divided into two groups: A, who were administered atorvastatin 40 mg daily for two months and 10 mg for next 4 months; and group B, 4 who were treated according to current guidelines without statin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Not described Receives: Drug: Tulip | |
| No statin | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular function
Measured: 2 months
Secondary outcomes (1)
mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Agata Bielecka-Dabrowa, PhD, Principal investigator, Department of Hypertension UM LodzMaciej Banach, Assoc. Prof., Study director, Department of Hypertension UM Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015144
- Sponsor's protocol ID
- 502-11-585
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2009
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bielecka-Dabrowa A, Wierzbicka M, Dabrowa M, Goch A. New methods in laboratory diagnostics of dilated cardiomyopathy. Cardiol J. 2008;15(4):388-95.
PubMed 18698552Bielecka-Dabrowa A, Wierzbicka M, Goch JH. [Proinflammatory cytokines in cardiovascular diseases as potential therapeutic target]. Wiad Lek. 2007;60(9-10):433-8. Polish.
PubMed 18350717Bielecka-Dabrowa A, Goch JH, Rysz J, Maciejewski M, Desai R, Aronow WS, Banach M. Influence of co-existing atrial fibrillation on the efficacy of atorvastatin treatment in patients with dilated cardiomyopathy: a pilot study. Lipids Health Dis. 2010 Feb 23;9:21. doi: 10.1186/1476-511X-9-21.
PubMed 20178563Bielecka-Dabrowa A, Goch JH, Mikhailidis DP, Rysz J, Maciejewski M, Banach M. The influence of atorvastatin on parameters of inflammation and function of the left ventricle in patients with dilated cardiomyopathy. Med Sci Monit. 2009 Dec;15(12):MS12-23.
PubMed 19946241
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle in Patients With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01015144
- Acronym / sponsor ID
- 502-11-585
- Conditions
- Dilated Cardiomyopathy
- Keywords
- atorvastatin, dilated cardiomyopathy, heart failure, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Nov 2009 (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 aim of the study was to assess of the influence of atorvastatin on selected indicators of an inflammatory condition, function of the left ventricle and factors affecting the occurrence of undesired events like rehospitalizations and mortality in patients with dilated cardiomyopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | – | Drug: Tulip |
| No statin | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dilated cardiomyopathy (according ESC 2007) with EF≤40% as documented by echocardiography were included.
Key inclusion criteria (4 listed)
- patients 18 years old or older
- patients who signed informed consent
- patients with dilated cardiomyopathy (according ESC 2007)
- patients who had no significant coronary artery stenoses >30% on cardiac catheterization
Key exclusion criteria (19 listed)
- BP ≥140/90 lub <90/60
- congenital heart disease
- acquired valvular disease except for mitral incompetence secondary to left ventricular dilatation
- New York Heart Association (NYHA) functional class IV
- statin treatment
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 |
|---|---|---|
| TulipPatients were divided into two groups: A, who were administered atorvastatin 40 mg daily for two months and 10 mg for next 4 months; and group B, 4 who were treated according to current guidelines without statin therapy. | Drug | Atorvastatin |
Primary outcome
left ventricular function
Time frame: 2 months
1 secondary outcome
mortality
Time frame: 6 months
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 18 Nov 2009.
- Background: PubMed 18698552Bielecka-Dabrowa A, Wierzbicka M, Dabrowa M, Goch A. New methods in laboratory diagnostics of dilated cardiomyopathy. Cardiol J. 2008;15(4):388-95.
- Background: PubMed 18350717Bielecka-Dabrowa A, Wierzbicka M, Goch JH. [Proinflammatory cytokines in cardiovascular diseases as potential therapeutic target]. Wiad Lek. 2007;60(9-10):433-8. Polish.
- Derived from this study: PubMed 20178563Bielecka-Dabrowa A, Goch JH, Rysz J, Maciejewski M, Desai R, Aronow WS, Banach M. Influence of co-existing atrial fibrillation on the efficacy of atorvastatin treatment in patients with dilated cardiomyopathy: a pilot study. Lipids Health Dis. 2010 Feb 23;9:21. doi: 10.1186/1476-511X-9-21.
- Derived from this study: PubMed 19946241Bielecka-Dabrowa A, Goch JH, Mikhailidis DP, Rysz J, Maciejewski M, Banach M. The influence of atorvastatin on parameters of inflammation and function of the left ventricle in patients with dilated cardiomyopathy. Med Sci Monit. 2009 Dec;15(12):MS12-23.
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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.
Agata Bielecka-Dabrowa, PhD principal investigator
Department of Hypertension UM Lodz
Maciej Banach, Assoc. Prof. study director
Department of Hypertension UM Lodz
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathy, run by Medical University of Lodz.
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 4 inclusion and 19 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 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
left ventricular function (time frame: 2 months). 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 NCT01015144, which also lists 4 linked publications.
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 18 Nov 2009.