Cardiomyopathy, DilatedNCT00612911
Cell Therapy in Dilated Cardiomyopathy: Observational Study
An observational study of Cardiomyopathy, Dilated, run by Ministry of Health, Brazil at 1 site in Brazil.
Trial summary
Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiomyopathy, Dilated
- What is being tested?
- Cell therapy
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2005to Aug 2007
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with idiopathic dilated cardiomyopathy
Who may be able to join
- Diagnosis of idiopathic dilated cardiomyopathy
- Optimized therapy and for idiopathic dilated cardiomyopathy
- Left ventricular ejection fraction (Simpson) < 35%
- Peak oxygen consumption (VO2 peak) < 16 mL.kg-1min-1
- Functional classes II-IV of the NYHA
Who cannot join
- dilated cardiopathies of ischemic or chagasic origin
- primary valve disease
- excessive use of alcohol or illicit drugs
- pregnancy
- ventricular arrhythmias
- any co-morbidity with impact on survival
Trial locations and contacts
1 site in 1 country.
Brazil1 site
INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Rio de Janeiro, 22.240-006
About this study
Official title: Cell Therapy in Dilated Cardiomyopathy: A Safety and Feasibility Study Using Autologous Bone Marrow Mononuclear Cells
Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy
Read the detailed description
Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction <35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months
- Conditions
- Cardiomyopathy, Dilated
- Being tested
- Cell therapy
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell therapyOther
bone marrow mononuclear cell
| Study group | Role | What they receive |
|---|---|---|
| Major group | Patients with Idiopathic dilated cardiomyopathy Receives: Other: Cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
echocardiography
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startFeb 2005
- Primary completionAug 2006
- Study completionAug 2007
Why it stopped: finish study as protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, DilatedStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Brazil
- Sponsor type
- Other government
- Investigators
- Helena F Martino, Principal investigator, Brazil: National Insittute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612911
- Sponsor's protocol ID
- CTDil-1
- Status last verified
- Jan 2008
- First submitted
- 23 Jan 2008
- Last updated
- 12 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Therapy in Dilated Cardiomyopathy: A Safety and Feasibility Study Using Autologous Bone Marrow Mononuclear Cells
- ClinicalTrials.gov ID
- NCT00612911
- Acronym / sponsor ID
- CTDil-1
- Conditions
- Cardiomyopathy, Dilated
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: finish study as protocol
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ministry of Health, BrazilOther government
- Study start
- Feb 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 12 Feb 2008 (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.
Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy
Detailed description
Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction <35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major group | – | Other: Cell therapyPatients with Idiopathic dilated cardiomyopathy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with idiopathic dilated cardiomyopathy
Key inclusion criteria (5 listed)
- Diagnosis of idiopathic dilated cardiomyopathy
- Optimized therapy and for idiopathic dilated cardiomyopathy
- Left ventricular ejection fraction (Simpson) < 35%
- Peak oxygen consumption (VO2 peak) < 16 mL.kg-1min-1
- Functional classes II-IV of the NYHA
Key exclusion criteria (6 listed)
- dilated cardiopathies of ischemic or chagasic origin
- primary valve disease
- excessive use of alcohol or illicit drugs
- pregnancy
- ventricular arrhythmias
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 |
|---|---|---|
| Cell therapybone marrow mononuclear cell | Other | Major group |
Primary outcome
echocardiography
Time frame: 2 months
Results and safety
The study was stopped early (reason given: finish study as protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2008.
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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.
Helena F Martino principal investigator
Brazil: National Insittute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, Dilated, run by Ministry of Health, Brazil at 1 site in Brazil.
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 6 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: stopped early, as of the sponsor's last update on 12 Feb 2008. 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 Brazil. 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.
Are results available for this study?
The study was stopped early (reason given: finish study as protocol). Results are not available in the source record.
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?
echocardiography (time frame: 2 months). 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 12 Feb 2008.