Heart FailureCCM-HFNCT02895048
Effects of CCM-therapy in Patients With Heart Failure
An observational study of Heart Failure, run by Stiftung Institut fuer Herzinfarktforschung at 1 site in Germany.
Trial summary
The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 184 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Nov 2013
- 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: The study shall include up to 300 subjects with CCM treatment and up to 300 subjects without CCM treatment. Patients without CCM treatment serve as Control patients and they will be recruited from centers not implanting OPTIMIZER systems.
Who may be able to join
- Any subject who receives an OPTIMIZER system implant and provides informed consent
- Symptomatic heart failure (NYHA Class 2, 3 or 4) despite receiving optimal medical therapy with doses of medications that are stable (no more than 50 % variation) for at least 7 days.
- EF ≤ 45%
- Signed informed consent
Who cannot join
- None
- Heart failure due to a potentially correctible cause ( e. g. valvular disease, congenital disease)
- Idiopathic hypertrophic cardiomyopathy, restrictive or constrictive cardiomyopathy, or heart failure on the basis of a known inflammatory or infiltrative disease (e. g. amyloidosis, sarcoidosis) or constrictive disease
- Active ischemia or exercise tolerance limited by angina
- Hospitalizations for heart failure which required the use of inotropic support within 14 days of enrollment
- Chronic (permanent or persistent) atrial fibrillation or atrial flutter
Show all 11Show fewer
- Scheduled for a CABG or a PCI procedure, or has undergone a CABG procedure within 90 days or a PCI procedure within 30 days of enrollment
- Myocardial infarction within 90 days of enrollment
- Hemodialysis or peritoneal dialysis
- Prior heart transplant
- Participating in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effects of Cardiac Contractility Modulation (CCM) With the OPTIMIZER III System in Subjects With Heart Failure Caused by Left Ventricular Dysfunction
The effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with heart failure.
Read the detailed description
The OPTIMIZER III System is indicated for use in patients greater than 18 years of age with symptomatic heart failure due to left ventricular systolic dysfunction despite appropriate medical therapy. The study will gather additional data on the effect of CCM treatment with the objective of determining the impact of CCM on the composite of heart failure hospitalizations and mortality in the low ejection fraction (EF < 35%) and mildly reduced ejection fraction (35 ≤ EF ≤ 45) heart failure population. The study will also assess the impact of CCM on exercise tolerance (six minute hall walk test, 6 Minute Walk Test) and quality of life (Minnesota Living With Heart Failure Questionnaire, MLWHFQ) in these same populations.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic heart failure | Not described | |
| CCM treatment | Subjects with heart failure receiving OPTIMIZER system implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause and cardiac mortality
Measured: 24 Months
Secondary outcomes (1)
the rate of all-cause and cardiac-related hospitalizations
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completionNov 2013
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Impulse Dynamics
- Responsible party
- Sponsor
- Investigators
- Andrew Remppis, Professor, Principal investigator, Bad Bevensen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895048
- Sponsor's protocol ID
- ID CP OPT2009-007
- Acronym
- CCM-HF
- Status last verified
- Jun 2016
- First submitted
- 7 Oct 2011
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Cardiac Contractility Modulation (CCM) With the OPTIMIZER III System in Subjects With Heart Failure Caused by Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT02895048
- Acronym / sponsor ID
- CCM-HF / ID CP OPT2009-007
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Impulse Dynamics
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Sep 2016 (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 effects of Cardiac Contractility Modulation (CCM) treatment are observed in patients with heart failure.
Detailed description
The OPTIMIZER III System is indicated for use in patients greater than 18 years of age with symptomatic heart failure due to left ventricular systolic dysfunction despite appropriate medical therapy. The study will gather additional data on the effect of CCM treatment with the objective of determining the impact of CCM on the composite of heart failure hospitalizations and mortality in the low ejection fraction (EF < 35%) and mildly reduced ejection fraction (35 ≤ EF ≤ 45) heart failure population. The study will also assess the impact of CCM on exercise tolerance (six minute hall walk test, 6 Minute Walk Test) and quality of life (Minnesota Living With Heart Failure Questionnaire, MLWHFQ) in these same populations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic heart failure | – | – |
| CCM treatment | – | –Subjects with heart failure receiving OPTIMIZER system implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study shall include up to 300 subjects with CCM treatment and up to 300 subjects without CCM treatment. Patients without CCM treatment serve as Control patients and they will be recruited from centers not implanting OPTIMIZER systems.
Key inclusion criteria (4 listed)
- Any subject who receives an OPTIMIZER system implant and provides informed consent
- Symptomatic heart failure (NYHA Class 2, 3 or 4) despite receiving optimal medical therapy with doses of medications that are stable (no more than 50 % variation) for at least 7 days.
- EF ≤ 45%
- Signed informed consent
Key exclusion criteria (11 listed)
- None
- Heart failure due to a potentially correctible cause ( e. g. valvular disease, congenital disease)
- Idiopathic hypertrophic cardiomyopathy, restrictive or constrictive cardiomyopathy, or heart failure on the basis of a known inflammatory or infiltrative disease (e. g. amyloidosis, sarcoidosis) or constrictive disease
- Active ischemia or exercise tolerance limited by angina
- Hospitalizations for heart failure which required the use of inotropic support within 14 days of enrollment
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
All-cause and cardiac mortality
Time frame: 24 Months
1 secondary outcome
the rate of all-cause and cardiac-related hospitalizations
Time frame: 24 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 9 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Andrew Remppis, Professor principal investigator
Bad Bevensen
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 Stiftung Institut fuer Herzinfarktforschung 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 4 inclusion and 11 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 9 Sep 2016. 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 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?
All-cause and cardiac mortality (time frame: 24 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 9 Sep 2016.