Heart FailureNCT00338156
Observational Study of the Remodelling Process Following Myocardial Infarct
An observational study of Heart Failure and Myocardial Infarct, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
This study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Myocardial Infarct
- How many people
- 119 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2003to Sep 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with risk of heart failure secondary to myocardial infarct.
Who may be able to join
- Participation in the previous neurohormonal substudy of the OPTIMAAL trial
- Willingness to participate in the present study and ability to understand and sign the written informed consent
Who cannot join
- Myocardial infarction within 3 months of visit 1.
- Significant primary valve disease, confirmed by ECHO cardiography,
- Autoimmune disease likely to cause an increase in collagen turnover
- Active cancer disease
- Immunosuppressive treatment,
- Significantly reduced liver function
- Contraindications for performing a cardiac MRI scan (including claustrophobia, implanted ferromagnetic devices or known allergic reactions to Omniscan™).
- Inability to cooperate during the 1 month follow up period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Relationship Between Collagen Turnover, Left Ventricular Remodelling and Myocardial Scarring Assessed by Cardiac Magnetic Resonance and Neurohumoral Activation in Patients With Previous Myocardial Infarction
This study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction.
Read the detailed description
A multinational trial compared losartan vs. captopril in 5477 postinfarction patients with symptoms of heart failure and/or evidence of left ventricular dysfunction. The trial was terminated in 2002 and the results of the main trial have been published. In this trial, a collagen and neurohumoral substudy was performed to assess the importance of collagen turnover in this population. A total of 235 patients were included from 18 centres. Blood was taken at randomisation, 1 month, 1 year and 2 years.
The present study will recruit surviving patients among the 119 individuals that were randomised to the neurohumoral substudy at the Stavanger University Hospital. The study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in these patients about 3 years following the index myocardial infarction.
The data collected at the 3-year follow-up visit will be compared to data from the initial study.
- Conditions
- Heart Failure, Myocardial Infarct
- Keywords
- Left Ventricle Remodelling, Collagen markers, Neurohormones, Cardiac MRI
- Medical subject headings
- Heart Failure, Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startAug 2003
- Primary completionSep 2003
- Study completionSep 2003
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Helse Vest, Amersham Buchler, GmbH & Co KG
- Responsible party
- Sponsor
- Investigators
- Kenneth Dickstein, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338156
- Sponsor's protocol ID
- StaHF461302
- Other IDs
- Helse Vest 911017
- Status last verified
- Jul 2010
- First submitted
- 16 Jun 2006
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationship Between Collagen Turnover, Left Ventricular Remodelling and Myocardial Scarring Assessed by Cardiac Magnetic Resonance and Neurohumoral Activation in Patients With Previous Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00338156
- Acronym / sponsor ID
- StaHF461302
- Conditions
- Heart Failure, Myocardial Infarct
- Keywords
- Left Ventricle Remodelling, Collagen markers, Neurohormones, Cardiac MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Helse Vest, Amersham Buchler, GmbH & Co KG
- Study start
- Aug 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 20 Jun 2006 (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.
This study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction.
Detailed description
A multinational trial compared losartan vs. captopril in 5477 postinfarction patients with symptoms of heart failure and/or evidence of left ventricular dysfunction. The trial was terminated in 2002 and the results of the main trial have been published. In this trial, a collagen and neurohumoral substudy was performed to assess the importance of collagen turnover in this population. A total of 235 patients were included from 18 centres. Blood was taken at randomisation, 1 month, 1 year and 2 years.
The present study will recruit surviving patients among the 119 individuals that were randomised to the neurohumoral substudy at the Stavanger University Hospital. The study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in these patients about 3 years following the index myocardial infarction.
The data collected at the 3-year follow-up visit will be compared to data from the initial study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with risk of heart failure secondary to myocardial infarct.
Key inclusion criteria (2 listed)
- Participation in the previous neurohormonal substudy of the OPTIMAAL trial
- Willingness to participate in the present study and ability to understand and sign the written informed consent
Key exclusion criteria (8 listed)
- Myocardial infarction within 3 months of visit 1.
- Significant primary valve disease, confirmed by ECHO cardiography,
- Autoimmune disease likely to cause an increase in collagen turnover
- Active cancer disease
- Immunosuppressive treatment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 28 Jul 2015.
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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.
Kenneth Dickstein, PhD principal investigator
Helse Stavanger HF
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 Heart Failure and Myocardial Infarct, run by Helse Stavanger HF 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 2 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 28 Jul 2015. 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. 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.
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 28 Jul 2015.