Heart FailureAUGMENT-HFIINCT03082508
A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure
A study testing Algisyl and Standard Medical Therapy in people with Heart Failure and Dilated Cardiomyopathy, run by LoneStar Heart, Inc..
Trial summary
AUGMENT-HF II is a study to evaluate the efficacy and safety of the Algisyl device. The purpose of this study is to investigate Algisyl employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Heart Failure, Dilated Cardiomyopathy, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Algisyl and Standard Medical Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Jan 2024
- 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
- 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.
- The patient must have cardiac resynchronization therapy (CRT) if clinically indicated, implanted ≥3 months prior to randomization.
- Note: In those patients not receiving CRT or CRT-D therapy the investigator should not anticipate initiating this therapy within 6 months after randomization
Show all 14Show fewer
- The patient must have an implanted cardio-defibrillator (ICD) if clinically indicated, implanted at least 30 days prior to randomization.
- Note: If the patient has clinical indications for an ICD but refuses the ICD, this refusal of ICD therapy must be document in the medical record and the patient may be enrolled with this documentation.
- 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 greater than or equal to 30 mm/m2 (LVEDD/BSA) and an LVEDD of greater than or equal to 85 mm (measured within the last 30 days)
- Patients must have symptomatic heart failure with a Peak VO2 of 9.0 - 15.0 ml/min/kg (performed using a treadmill). Patients must perform two CPX tests (within 30 days of randomization 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 - 15.0 ml/min/kg from these two tests. All CPX tests performed for the study must have a Peak Respiratory Exchange Ratio (RER) of at least 1.0 to be accepted as a valid test.
- Patient's surgical risk must be considered reasonable and the evaluation of surgical risk should include review of coronary and left ventricular angiography. Surgical risk assessment should include the consideration of risk presented by prior surgical procedures such as prior mid-sternotomy surgical procedures.
- Note: investigators should observe standard clinical practice for the management of antithrombotic therapy in patients undergoing surgical procedures in accordance with the American College of Chest Physicians Guidelines: Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th edition
- 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 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
- Patients with a recent history of stroke (within 60 days prior to the surgical procedure)
Show all 12Show fewer
- 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 an estimated glomerular filtration rate (GFR) < 30 mL/min/1.73 m2
- 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
No sites are listed yet.
About this study
AUGMENT-HF II is a study to evaluate the efficacy and safety of the Algisyl device. The purpose of this study is to investigate Algisyl employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy.
Algisyl will be injected into the myocardium under direct visualization during the surgical procedure. Structural abnormalities in the heart are known to play a central role in HF, and clinical evidence supports a strong causal relationship between cardiac chamber dilation and heart failure. Because dilation, and not contractile dysfunction, appears to be responsible for the severity of the disease, the mitigation or prevention of the deleterious structural abnormalities of the left ventricle appears to be an important therapeutic target for patients with this life threatening illness.
Read more
Hence, a therapy that specifically reduces LV wall stress, targets LV dilatation and LV remodeling may offer an important new alternative in the treatment of heart failure. Algisyl is being investigated based on evidence that suggests an ability of the implants to reduce wall stress, reshape the LV chamber and reduce the LV chamber size as well as prevent the progressive ventricular dilation and remodeling associated with HF.
The physiologic response to progressive exercise using direct measures of ventilation and gas exchange via the cardiopulmonary exercise test is an important diagnostic tool in the management of the patient with HF, quantifying responses to therapy, and as a reliable prognostic utility for predicting outcomes in patients with HF.
Numerous studies have established the strong association of peak VO2 with mortality and morbidity risk in HF. Peak VO2 conceptually is considered an overall global marker of cardiopulmonary health and is a reflection of the degree of impairment in ventricular function ( the heart's pumping capacity), oxygen delivery and oxygen utilization.
Hence, employing the change in peak VO2 as a primary endpoint in this clinical study provides a strong objective measure that can be interpreted in independent blinded fashion, to evaluate the result of the therapeutic intervention and provide an equally strong assessment of the prognostic implications for patients in the study.
This clinical evaluation is intended to provide confirmatory evidence of the effectiveness and safety of the device Algisyl in patients with advanced heart failure.
- Being tested
- Algisyl, Standard Medical Therapy
- Keywords
- Algisyl, Heart Failure, Dilated Cardiomyopathy, Alginate Hydrogel, Heart Failure with Reduced Ejection Fraction, Congestive Heart Failure
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgisylDevice
Also called intramyocardial injections of alginate hydrogel
Algisyl device (implants) administered during a surgical procedure
Standard Medical TherapyDrug
Also called Evidence based therapy for heart failure, heart failure medications, drug therapy
as per protocol
| Study group | Role | What they receive |
|---|---|---|
| Algisyl | Experimental | Algisyl device (implants) administered during a surgical procedure. Receives: Device: Algisyl |
| Standard Medical Therapy | Active comparator | as per protocol Receives: Drug: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2
Change in Peak VO2 from baseline to 6 months of follow-up
Measured: 6 months
Primary Safety Endpoint: Death or Re-hospitalization for Worsening Heart Failure
Death or Re-hospitalization for Worsening Heart Failure
Measured: 12 months
Secondary outcomes (4)
NYHA Functional Class
NYHA Functional Class
Measured: 6 months
Six-minute walk distance
Six minute walk distance
Measured: 6 months
Peak VO2 at 12 months
Change in Peak VO2 from baseline to 12 months of follow-up
Measured: 12 months
QOL
Quality of Life as measured by KCCQ (Kansas City Cardiomyopathy Questionnaire)
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 posted17 Mar 2017
- Study startAug 2017 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2024 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LoneStar Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082508
- Sponsor's protocol ID
- LSH-14-001
- Acronym
- AUGMENT-HFII
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure
- ClinicalTrials.gov ID
- NCT03082508
- Acronym / sponsor ID
- AUGMENT-HFII / LSH-14-001
- Keywords
- Algisyl, Heart Failure, Dilated Cardiomyopathy, Alginate Hydrogel, Heart Failure with Reduced Ejection Fraction, Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- LoneStar Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2017 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 17 Mar 2017 (actual)
- 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.
AUGMENT-HF II is a study to evaluate the efficacy and safety of the Algisyl device. The purpose of this study is to investigate Algisyl employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy.
Algisyl will be injected into the myocardium under direct visualization during the surgical procedure. Structural abnormalities in the heart are known to play a central role in HF, and clinical evidence supports a strong causal relationship between cardiac chamber dilation and heart failure. Because dilation, and not contractile dysfunction, appears to be responsible for the severity of the disease, the mitigation or prevention of the deleterious structural abnormalities of the left ventricle appears to be an important therapeutic target for patients with this life threatening illness.
Hence, a therapy that specifically reduces LV wall stress, targets LV dilatation and LV remodeling may offer an important new alternative in the treatment of heart failure. Algisyl is being investigated based on evidence that suggests an ability of the implants to reduce wall stress, reshape the LV chamber and reduce the LV chamber size as well as prevent the progressive ventricular dilation and remodeling associated with HF.
The physiologic response to progressive exercise using direct measures of ventilation and gas exchange via the cardiopulmonary exercise test is an important diagnostic tool in the management of the patient with HF, quantifying responses to therapy, and as a reliable prognostic utility for predicting outcomes in patients with HF.
Numerous studies have established the strong association of peak VO2 with mortality and morbidity risk in HF. Peak VO2 conceptually is considered an overall global marker of cardiopulmonary health and is a reflection of the degree of impairment in ventricular function ( the heart's pumping capacity), oxygen delivery and oxygen utilization.
Hence, employing the change in peak VO2 as a primary endpoint in this clinical study provides a strong objective measure that can be interpreted in independent blinded fashion, to evaluate the result of the therapeutic intervention and provide an equally strong assessment of the prognostic implications for patients in the study.
This clinical evaluation is intended to provide confirmatory evidence of the effectiveness and safety of the device Algisyl in patients with advanced heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algisyl | Experimental | Device: AlgisylAlgisyl device (implants) administered during a surgical procedure. |
| Standard Medical Therapy | Active comparator | Drug: Standard Medical Therapyas per protocol |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- The patient must have cardiac resynchronization therapy (CRT) if clinically indicated, implanted ≥3 months prior to randomization.
Key exclusion criteria (12 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 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
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 |
|---|---|---|
| AlgisylAlso: intramyocardial injections of alginate hydrogelAlgisyl device (implants) administered during a surgical procedure | Device | Algisyl |
| Standard Medical TherapyAlso: Evidence based therapy for heart failure, heart failure medications, drug therapyas per protocol | Drug | Standard Medical Therapy |
Primary outcome
Peak VO2
Time frame: 6 months
Change in Peak VO2 from baseline to 6 months of follow-up
Primary Safety Endpoint: Death or Re-hospitalization for Worsening Heart Failure
Time frame: 12 months
Death or Re-hospitalization for Worsening Heart Failure
4 secondary outcomes
NYHA Functional Class
Time frame: 6 months
Six-minute walk distance
Time frame: 6 months
Peak VO2 at 12 months
Time frame: 12 months
QOL
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Questions about this trial
What is this clinical trial studying?
A study testing Algisyl and Standard Medical Therapy in people with Heart Failure and Dilated Cardiomyopathy, run by LoneStar Heart, Inc..
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 14 inclusion and 12 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 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Manoj Raghuraman (949-679-6185 ext. 101, mraghuraman@Lshmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 (time frame: 6 months). The study lists 2 primary outcomes in all. 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 17 Mar 2017.