Heart FailureNCT00180401
MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Patients With QRS-Complex of 120 - 150 Ms
An observational study of Heart Failure, run by Boston Scientific Corporation at 1 site in Germany.
Trial summary
The purpose of this study is to compare the benefit of cardiac resynchronization therapy (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT-P and CRT-D devices
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2002to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cardiac resynchronization therapy with a defibrillator (CRT-D) or cardiac resynchronization therapy pacemakers (CRT-P) system
- New York Heart Association (NYHA) III
- Ejection fraction (EF) below 35%
- Optimised medical therapy
- QRS-complex above 120 ms
Who cannot join
- Patients with CRT-P and atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der Christian Albrecht Universität / Kardiologische Abteilung
Kiel, 24105
About this study
Official title: MODULA-Study: Modul 10: Benefit of CRT-therapy in CRT-Patients With QRS-complex of 120 - 150 ms
The purpose of this study is to compare the benefit of cardiac resynchronization therapy (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms.
Read the detailed description
The objective of this study is to compare the benefit of CRT-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms within 12 months. A benefit is defined as change in quality of life and change in physical ability.
- Conditions
- Heart Failure
- Being tested
- CRT-P and CRT-D devices
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-P and CRT-D devicesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| QRS 120-150 ms | Subjects with a QRS width between 120-150 ms Receives: Behavioral: CRT-P and CRT-D devices | |
| QRS >150 ms | Subjects with a QRS width >150 ms Receives: Behavioral: CRT-P and CRT-D devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational: Benefit of CRT
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2002
- Study completionOct 2007
Why it stopped: no longer interest from medical community
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.
- More trials run by Boston Scientific CorporationThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Investigators
- Andreas Tiroke, MD, Principal investigator, Klinikum der Christian Albrecht Universität / Kardiologische Abteilung / Arnold Heller-Str. 7 / 24105 Kiel / Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180401
- Sponsor's protocol ID
- Version vom 05.08.2002
- Status last verified
- Feb 2017
- First submitted
- 12 Sep 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MODULA-Study: Modul 10: Benefit of CRT-therapy in CRT-Patients With QRS-complex of 120 - 150 ms
- ClinicalTrials.gov ID
- NCT00180401
- Acronym / sponsor ID
- Version vom 05.08.2002
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: no longer interest from medical community
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Study start
- Jun 2002
- Study completion
- Oct 2007 (actual)
- First posted
- 16 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.
The purpose of this study is to compare the benefit of cardiac resynchronization therapy (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms.
Detailed description
The objective of this study is to compare the benefit of CRT-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms within 12 months. A benefit is defined as change in quality of life and change in physical ability.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QRS 120-150 ms | – | Behavioral: CRT-P and CRT-D devicesSubjects with a QRS width between 120-150 ms |
| QRS >150 ms | – | Behavioral: CRT-P and CRT-D devicesSubjects with a QRS width >150 ms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with cardiac resynchronization therapy with a defibrillator (CRT-D) or cardiac resynchronization therapy pacemakers (CRT-P) system
- New York Heart Association (NYHA) III
- Ejection fraction (EF) below 35%
- Optimised medical therapy
- QRS-complex above 120 ms
Key exclusion criteria (1 listed)
- Patients with CRT-P and atrial fibrillation
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 |
|---|---|---|
| CRT-P and CRT-D devices | Behavioural | QRS 120-150 ms, QRS >150 ms |
Primary outcome
Observational: Benefit of CRT
Time frame: 12 month
Results and safety
The study was stopped early (reason given: no longer interest from medical community). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
Andreas Tiroke, MD principal investigator
Klinikum der Christian Albrecht Universität / Kardiologische Abteilung / Arnold Heller-Str. 7 / 24105 Kiel / Germany
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, run by Boston Scientific Corporation 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 1 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 23 Feb 2017. 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.
Are results available for this study?
The study was stopped early (reason given: no longer interest from medical community). 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?
Observational: Benefit of CRT (time frame: 12 month). 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 23 Feb 2017.