Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01311791




Registration number
NCT01311791
Ethics application status
Date submitted
8/03/2011
Date registered
10/03/2011
Date last updated
15/03/2017

Titles & IDs
Public title
A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure
Scientific title
A Randomized, Controlled Study to Evaluate the Safety and Cardiovascular Effects of Algisyl-LVR™ as a Method of Left Ventricular Augmentation in Patients With Dilated Cardiomyopathy (AUGMENT-HF)
Secondary ID [1] 0 0
LSH-10-001
Universal Trial Number (UTN)
Trial acronym
AUGMENT-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Dilated Cardiomyopathy 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Algisyl-LVR
Treatment: Drugs - Standard medical therapy

Experimental: Algisyl-LVR - Algisyl-LVR™ device (implants) administered during a surgical procedure.

Active comparator: Standard Medical Therapy - as per protocol


Treatment: Devices: Algisyl-LVR
Algisyl-LVR™ device (implants) administered during a surgical procedure

Treatment: Drugs: Standard medical therapy
as defined per protocol
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
peak VO2
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
30 day all cause mortality
Timepoint [1] 0 0
30 days

Eligibility
Key inclusion criteria
1. The patients must be able and willing to give written informed consent
2. The patients will be adult (age = 18 years and = 79 years) males or females
3. The patients must be on stable, evidence-based therapy for heart failure

* Note: CRT or CRT-D are acceptable co-therapy, if placed > 3 months before randomization or the investigator does not anticipate within 6 months after randomization
4. 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)
5. 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)
6. 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 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 - 14.5 ml/min/kg from these two tests.
7. Patient's surgical risk must be considered reasonable and the evaluation of surgical risk should include review of coronary and left ventricular angiography
8. 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
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD within the next 6 months.
2. Patients presenting with cardiogenic shock.
3. 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.
4. Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis
5. Patient with a history of constrictive pericarditis
6. Patients with a Q wave myocardial infarction (MI) within the last 30 days
7. Patients with a recent history of stroke (within 60 days prior to the surgical procedure)
8. 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)
9. Patients with a serum creatinine > 2.5 mg/dL
10. Clinically significant liver enzyme abnormalities, i.e., AST(SGOT) and ALT (SGPT) more than 2.5 times the upper limit of normal
11. History of severe COPD (i.e., FEV 1< 1 liter or FEV1 < 50% predicted)
12. 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
13. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Heart Center at the Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
Germany
State/province [2] 0 0
Dresden
Country [3] 0 0
Germany
State/province [3] 0 0
Kiel
Country [4] 0 0
Germany
State/province [4] 0 0
Ulm
Country [5] 0 0
Italy
State/province [5] 0 0
Milanese (MI)
Country [6] 0 0
Italy
State/province [6] 0 0
Bergamo
Country [7] 0 0
Italy
State/province [7] 0 0
Cremona
Country [8] 0 0
Italy
State/province [8] 0 0
Milan
Country [9] 0 0
Italy
State/province [9] 0 0
Padova
Country [10] 0 0
Italy
State/province [10] 0 0
Rome
Country [11] 0 0
Netherlands
State/province [11] 0 0
Nieuwegein
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
Romania
State/province [13] 0 0
Bucharest

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LoneStar Heart, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maurizio Volterani, MD
Address 0 0
IRCCS San Raffaele Pisana
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT01311791