Congestive Heart FailurePhase 1NCT01251185
Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure
A Phase 1 study testing Cardiospec in people with Congestive Heart Failure, run by Medispec at 1 site in Israel.
Trial summary
Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Cardiospec
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 1
- 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
- Patient is male or female 18 years or older.
- Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.
- Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.
- Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.
- Patient is classified as NYHA II to IV.
- Patient should be on a stable dosage of medication for at least 6 weeks prior to enrollment.
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- Patients Ejection Fraction < 50%.
- Patient is stable and without clinical events for > 3 months.
- Patient has signed an informed consent form.
- Patient's condition should be stable and should have a life expectancy of >12 months.
- Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's)medical opinion.
Who cannot join
- Patient with intraventricular thrombus.
- Severe COPD (patients with an FEV1 less than .8 liters).
- Patient has chronic lung disease including emphysema and pulmonary fibrosis.
- Patient has active endocarditis, myocarditis or pericarditis.
- Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
- Patients who are unwilling or unable to cooperate with study procedure.
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- Patients who are unwilling to quit smoking during the study procedure (including screening phase).
- Patients who are diagnosed with severe valvular disease (regurgitation or stenosis).
- Patient is pregnant.
- Patient with a malignancy in the area of treatment without complete remission within 5 years(lungs, thorax, ribs).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.
Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.
- Conditions
- Congestive Heart Failure
- Being tested
- Cardiospec
- Keywords
- Extracorporeal Shockwave Therapy, Heart Failure, Congestive Heart Failure, Non-invasive, Device Trial, NYHA (New York Heart Association), Ischemic cardiomyopathy, Ischemia, Myocardial contractility
- Medical subject headings
- Heart Failure, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiospecDevice
Also called Cardiospec ESMR therapy, Extracorporeal Shockwave therapy, Extracorporeal myocardial Revascularization
Non-invasive, low-intensity extracoporeal shockwaves at energy density of 0.99 mJ/mm2. 9 treatment sessions, 20 minutes each, over a period of 9 weeks (3 sessions on weeks 1, 5 and 9).
| Study group | Role | What they receive |
|---|---|---|
| CHF | Experimental | Single-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology. Receives: Device: Cardiospec |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the number of myocardial segments that improve their contractility(at rest and at stress)at 6 months post baseline evaluations, evaluated by echocardiography.
An echo examination shall be used to evaluate myocardial contractility post treatments.
Measured: 6 months
Secondary outcomes (1)
6 Minutes Walk Test (6MWT)
Evaluation of 6MWT time from baseline to 6 months post baseline.
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 posted1 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medispec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor
- Investigators
- Hilton Miller, Professor, Principal investigator, Tel Aviv Souraski Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251185
- Sponsor's protocol ID
- ESMR CHF-IL
- Status last verified
- Feb 2013
- First submitted
- 30 Nov 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.
- ClinicalTrials.gov ID
- NCT01251185
- Acronym / sponsor ID
- ESMR CHF-IL
- Conditions
- Congestive Heart Failure
- Keywords
- Extracorporeal Shockwave Therapy, Heart Failure, Congestive Heart Failure, Non-invasive, Device Trial, NYHA (New York Heart Association), Ischemic cardiomyopathy, Ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- MedispecIndustry (pharma, biotech, devices)
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Dec 2010 (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.
Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHF | Experimental | Device: CardiospecSingle-arm, open label, subjects with Congestive Heart Failure, with ischemic etiology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is male or female 18 years or older.
- Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.
- Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.
- Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.
- Patient is classified as NYHA II to IV.
Key exclusion criteria (10 listed)
- Patient with intraventricular thrombus.
- Severe COPD (patients with an FEV1 less than .8 liters).
- Patient has chronic lung disease including emphysema and pulmonary fibrosis.
- Patient has active endocarditis, myocarditis or pericarditis.
- Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.
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 |
|---|---|---|
| CardiospecAlso: Cardiospec ESMR therapy, Extracorporeal Shockwave therapy, Extracorporeal myocardial RevascularizationNon-invasive, low-intensity extracoporeal shockwaves at energy density of 0.99 mJ/mm2. 9 treatment sessions, 20 minutes each, over a period of 9 weeks (3 sessions on weeks 1, 5 and 9). | Device | CHF |
Primary outcome
The change in the number of myocardial segments that improve their contractility(at rest and at stress)at 6 months post baseline evaluations, evaluated by echocardiography.
Time frame: 6 months
An echo examination shall be used to evaluate myocardial contractility post treatments.
1 secondary outcome
6 Minutes Walk Test (6MWT)
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 20 Feb 2013.
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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.
Hilton Miller, Professor principal investigator
Tel Aviv Souraski Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cardiospec in people with Congestive Heart Failure, run by Medispec at 1 site in Israel.
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 11 inclusion and 10 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 20 Feb 2013. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The change in the number of myocardial segments that improve their contractility(at rest and at stress)at 6 months post baseline evaluations, evaluated by echocardiography. (time frame: 6 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 20 Feb 2013.