Heart FailureNCT02226679
An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001
A study testing Algisyl-LVR in people with Heart Failure and Cardiomyopathy, run by LoneStar Heart, Inc. at 2 sites in 2 countries.
Trial summary
The objective of this extension study is to evaluate the safety and potential beneficial effects of the Algisyl-LVR™ device in patients with established heart failure secondary to a dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Heart Failure, Cardiomyopathy, Dilated Cardiomyopathy
- What is being tested?
- Algisyl-LVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2014to Apr 2016
- Phase
- Interventional
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who completed at least 12 months of follow in the control group of the lead-in study LSH-10-001 are eligible to participate.
- Patients must have completed all study related procedures for the 12 month, 18 month or 24 month visit in Protocol LSH-10-001. Study procedures completed for the 12, 18 or 24 month visit in study LSH1-10-001 will be used as the baseline (screening) and qualifying procedures for study LSH-11-001 if the procedure was performed within 60 days of the date of Algisyl-LVR implant (screening procedures outside this window must be repeated).
- The patients must be able and willing to give written informed consent
- The patients will be adult (age ≥ 18 years and ≤ 79 years) males or females
- The patients must be on stable, evidence-based therapy for heart failure
- Evidence-based therapy for heart failure is defined as an ACE-inhibitor (ACE-I), and/or angiotensin II receptor blockers (ARB) for patients at stable doses for 1 month prior to enrollment, if tolerated, and a beta blocker (carvedilol, metoprolol succinate, Nebivolol or bisoprolol) for 3 months prior to enrollment, if tolerated. Recent up-titration of the beta blocker is acceptable if the patient has been stable on this dose for 1 month prior to enrollment. Stable is defined as no more than a 100% increase or a 50% decrease in dose. Contraindications or intolerance to therapies should be documented. In those intolerant to both ACE-I and ARB, combination therapy with hydralazine and oral nitrate should be considered. Therapeutic equivalence for ACE-I substitutions is allowed within the enrollment stability timelines. Aldosterone inhibitor therapy should be added when NYHA Class III or IV symptoms occur on standard therapy. If aldosterone inhibitor therapy is to be administered in NYHA Class II patients, it must be initiated and optimized prior to enrollment. Eplerenone requires dosage stability for 1 month prior to enrollment. Diuretics should be used as necessary to keep the patient euvolemic. All heart failure therapeutics and dosages should be documented in the Case Report Forms.
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- Note: CRT or CRT-D are acceptable co-therapy, if placed > 3 months before implant of Algisyl-LVR or the investigator does not anticipate within 6 months after enrollment
- The patients will have a left ventricular ejection fraction equal to or less than 35% via echocardiography, cardiac catheterization, radionuclide scan, or magnetic resonance imaging (measured within the last 30 days)
- The patients will have a left ventricular end diastolic dimension indexed to body surface area (LVEDDi) of 30 to 40mm/m2 (LVEDD/BSA) (measured within the last 30 days).
- Patients must have symptomatic heart failure with a Peak VO2 of 9.0 - 14.5 ml/min/kg (performed using a bicycle ergometer). Patients must perform two CPX tests (within 60 days of the Algisyl-LVR procedure and performed at least 20 hours apart) that differ by no more than 15% in the observed value for Peak VO2 and have a mean value of 9.0 - 14.5 ml/min/kg from these two tests.
- Patient's surgical risk must be considered reasonable and the evaluation of surgical risk should include review of coronary and left ventricular angiography.
- If female, the patients must be (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of study device.
Who cannot join
- Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD within the next 6 months
- Patients presenting with cardiogenic shock
- Patients who have undergone a previous mid-sternotomy surgical procedure are excluded unless the surgeon's assessment is that the left sided limited thoracotomy is feasible and considered reasonable surgical risk
- Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis
- Patient with a history of constrictive pericarditis
- Patients with a Q wave myocardial infarction (MI) within the last 30 days
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- Patients with a recent history of stroke (within 60 days prior to the surgical procedure)
- A left ventricular (LV) wall thickness of the LV free-wall, at the mid-ventricular level, of less than 8 mm (screening echocardiography must confirm a minimum wall thickness of 8 mm)
- Patients with a serum creatinine > 2.5 mg/dL
- Clinically significant liver enzyme abnormalities, i.e., AST(SGOT) and ALT (SGPT) more than 2.5 times the upper limit of normal
- History of severe COPD (i.e., FEV 1< 1 liter or FEV1 < 50% predicted)
- The patients will not be receiving concurrently an investigational Product in another clinical trial or have received an investigational Product in another clinical trial in the 30 days prior to enrollment
- A life expectancy of less than 1 year or any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Romania1 site
Emergency Clinic Center of The Army for The Cardiovascular Diseases
Bucharest
About this study
Official title: An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001 (Rollover Study for AUGMENT-HF)
The objective of this extension study is to evaluate the safety and potential beneficial effects of the Algisyl-LVR™ device in patients with established heart failure secondary to a dilated cardiomyopathy. The results of this study will provide confirmatory evidence of the long-term safety and effectiveness of the Algisyl-LVR in patients with established heart failure.
Read the detailed description
This is a prospective, open-label evaluation of the safety and effectiveness of Algisyl-LVR in patients with dilated cardiomyopathy of either ischemic or non-ischemic origin. The evaluation for the primary measure of efficacy (Peak VO2) at 6 months will be investigator-blinded. The primary safety endpoint, while not blinded, is 30 day all-cause mortality and an objective assessment. The remaining study endpoints will evaluate the effects of the device through the evaluation of functional, structural, biochemical, and electrocardiographic evaluations at 6 and 12 months. Evaluation of adverse events and these assessments will also provide evidence of the safety profile of the device in patients with dilated cardiomyopathy.
Pre-enrollment baseline patient evaluation will include clinical assessment, assessment of New York Heart Association (NYHA) functional class, blood tests, transthoracic echocardiography, MRI, electrocardiogram, cardiopulmonary exercise testing (CPX), submaximal exercise testing, and quality of life assessments. Blinded central evaluation will be performed for measures of cardiopulmonary exercise testing and cardiac imaging.
*Note: The local CPX and echocardiography measurements will be used to determine patient eligibility with respect to the peak V02 values, ejection fraction and the left ventricular end diastolic dimension indexed to body surface area (LVEDDi). The core lab values for these same assessments will be used in all statistical analyses of the study.
Patient's eligible for this study completed at least 12 months of follow in the control group of the lead-in study LSH-10-001 and provided a written informed consent to participate in study LSH-001. A written informed consent to be enrolled in study LSH-11-001 is required for all patients electing participation in this roll-over study. After written patient informed consent has been obtained and verification of eligibility, patients who meet the inclusion and exclusion criteria can be included in the study and will have the Algisyl-LVR™ device (implants) administered during a surgical procedure. Patients will be considered part of this study cohort as soon as they have been hospitalized to receive the Algisyl-LVR device. The investigator will complete the "Premature Withdrawal from Follow-up" form in the patient's eCRF for study LSH-10-001 and indicate "Patient will receive the Algisyl-LVR device" as the reason for premature withdrawal from LSH-10-001. The acute response to device implant will be monitored intraoperatively via continuous electrocardiographic cardiac monitoring, arterial pressure lines, transesophageal echocardiography (TEE), and pulmonary artery catheter. Patients receiving the investigational device are expected to remain hospitalized for 5 to 14 days.
Follow-up in this study is divided into two phases. During the first phase, referred to as the "efficacy phase", repeat testing of patient functional and cardiac structural parameters will be conducted at follow-up visits scheduled at 3 months and 6 months, and every 6 months thereafter. Follow-up testing will be supplemented by a 30 day (post implant) telephone contact with all patients. The efficacy phase of the trial will end on a common closing date after a minimum of 6 months of follow-up (i.e., after the last patient enrolled has been completed the 6 month visit). At that point data analysis will be performed and an initial study report will be generated. Following completion of the efficacy phase, long-term monitoring will continue through each patient's 24-month visit. This second phase is referred to as the "extended follow-up phase". During this phase, data collection will be focused on long-term safety and will be conducted at 6-month intervals.
- Conditions
- Heart Failure, Cardiomyopathy, Dilated Cardiomyopathy
- Being tested
- Algisyl-LVR
- Keywords
- crossover, rollover study, open label
- Medical subject headings
- Heart Failure, Cardiomyopathies, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algisyl-LVRDevice
Algisyl-LVR™ device (implants) administered during a surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Algisyl-LVR device implantation | Experimental | Algisyl-LVR™ employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy. Algisyl-LVR™ will be injected into the myocardium under direct visualization during the surgical procedure. Receives: Device: Algisyl-LVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device
The primary safety objective is to estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LoneStar Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ionel Droc, MD, Principal investigator, Emergency Clinic Center for The Army For the Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226679
- Sponsor's protocol ID
- LSH-11-001
- Status last verified
- Aug 2014
- First submitted
- 25 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001 (Rollover Study for AUGMENT-HF)
- ClinicalTrials.gov ID
- NCT02226679
- Acronym / sponsor ID
- LSH-11-001
- Conditions
- Heart Failure, Cardiomyopathy, Dilated Cardiomyopathy
- Keywords
- crossover, rollover study, open label
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- LoneStar Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 27 Aug 2014 (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 objective of this extension study is to evaluate the safety and potential beneficial effects of the Algisyl-LVR™ device in patients with established heart failure secondary to a dilated cardiomyopathy. The results of this study will provide confirmatory evidence of the long-term safety and effectiveness of the Algisyl-LVR in patients with established heart failure.
Detailed description
This is a prospective, open-label evaluation of the safety and effectiveness of Algisyl-LVR in patients with dilated cardiomyopathy of either ischemic or non-ischemic origin. The evaluation for the primary measure of efficacy (Peak VO2) at 6 months will be investigator-blinded. The primary safety endpoint, while not blinded, is 30 day all-cause mortality and an objective assessment. The remaining study endpoints will evaluate the effects of the device through the evaluation of functional, structural, biochemical, and electrocardiographic evaluations at 6 and 12 months. Evaluation of adverse events and these assessments will also provide evidence of the safety profile of the device in patients with dilated cardiomyopathy.
Pre-enrollment baseline patient evaluation will include clinical assessment, assessment of New York Heart Association (NYHA) functional class, blood tests, transthoracic echocardiography, MRI, electrocardiogram, cardiopulmonary exercise testing (CPX), submaximal exercise testing, and quality of life assessments. Blinded central evaluation will be performed for measures of cardiopulmonary exercise testing and cardiac imaging.
*Note: The local CPX and echocardiography measurements will be used to determine patient eligibility with respect to the peak V02 values, ejection fraction and the left ventricular end diastolic dimension indexed to body surface area (LVEDDi). The core lab values for these same assessments will be used in all statistical analyses of the study.
Patient's eligible for this study completed at least 12 months of follow in the control group of the lead-in study LSH-10-001 and provided a written informed consent to participate in study LSH-001. A written informed consent to be enrolled in study LSH-11-001 is required for all patients electing participation in this roll-over study. After written patient informed consent has been obtained and verification of eligibility, patients who meet the inclusion and exclusion criteria can be included in the study and will have the Algisyl-LVR™ device (implants) administered during a surgical procedure. Patients will be considered part of this study cohort as soon as they have been hospitalized to receive the Algisyl-LVR device. The investigator will complete the "Premature Withdrawal from Follow-up" form in the patient's eCRF for study LSH-10-001 and indicate "Patient will receive the Algisyl-LVR device" as the reason for premature withdrawal from LSH-10-001. The acute response to device implant will be monitored intraoperatively via continuous electrocardiographic cardiac monitoring, arterial pressure lines, transesophageal echocardiography (TEE), and pulmonary artery catheter. Patients receiving the investigational device are expected to remain hospitalized for 5 to 14 days.
Follow-up in this study is divided into two phases. During the first phase, referred to as the "efficacy phase", repeat testing of patient functional and cardiac structural parameters will be conducted at follow-up visits scheduled at 3 months and 6 months, and every 6 months thereafter. Follow-up testing will be supplemented by a 30 day (post implant) telephone contact with all patients. The efficacy phase of the trial will end on a common closing date after a minimum of 6 months of follow-up (i.e., after the last patient enrolled has been completed the 6 month visit). At that point data analysis will be performed and an initial study report will be generated. Following completion of the efficacy phase, long-term monitoring will continue through each patient's 24-month visit. This second phase is referred to as the "extended follow-up phase". During this phase, data collection will be focused on long-term safety and will be conducted at 6-month intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Algisyl-LVR device implantation | Experimental | Device: Algisyl-LVRAlgisyl-LVR™ employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy. Algisyl-LVR™ will be injected into the myocardium under direct visualization during the surgical procedure. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who completed at least 12 months of follow in the control group of the lead-in study LSH-10-001 are eligible to participate.
- Patients must have completed all study related procedures for the 12 month, 18 month or 24 month visit in Protocol LSH-10-001. Study procedures completed for the 12, 18 or 24 month visit in study LSH1-10-001 will be used as the baseline (screening) and qualifying procedures for study LSH-11-001 if the procedure was performed within 60 days of the date of Algisyl-LVR implant (screening procedures outside this window must be repeated).
- The patients must be able and willing to give written informed consent
- The patients will be adult (age ≥ 18 years and ≤ 79 years) males or females
- The patients must be on stable, evidence-based therapy for heart failure
Key exclusion criteria (13 listed)
- Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD within the next 6 months
- Patients presenting with cardiogenic shock
- Patients who have undergone a previous mid-sternotomy surgical procedure are excluded unless the surgeon's assessment is that the left sided limited thoracotomy is feasible and considered reasonable surgical risk
- Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis
- Patient with a history of constrictive pericarditis
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 |
|---|---|---|
| Algisyl-LVRAlgisyl-LVR™ device (implants) administered during a surgical procedure | Device | Algisyl-LVR device implantation |
Primary outcome
estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device
Time frame: 30 days
The primary safety objective is to estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
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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.
Ionel Droc, MD principal investigator
Emergency Clinic Center for The Army For the Cardiovascular Diseases
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algisyl-LVR in people with Heart Failure and Cardiomyopathy, run by LoneStar Heart, Inc. at 2 sites in 2 countries.
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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Romania. 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?
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?
estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device (time frame: 30 days). 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 27 Aug 2014.