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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - The primary effectiveness endpoint will be a comparison of change in Peak VO2 from baseline to 6 months of follow-up between the Algisyl-LVR and medically managed arms with the intention to prove superiority in improvement in Peak VO2 associated with the Algisyl-LVR study group as compared to the medically managed study group. Evaluation of the cardiopulmonary exercise testing will be conducted by a central, blinded core laboratory.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
30 day all cause mortality - The primary safety objective is to estimate the 30 day cardiac mortality associated with the implantation of the Algisyl-LVR device and qualitatively compare the observed rate to literature estimates for similar patients undergoing cardiac surgeries comparable in risk to implantation of the Algisyl-LVR
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
Gender
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/Phase 3
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The
purpose of this study is to investigate 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.

This study will evaluate the concept that direct mid left ventricular (LV) intramyocardial
injections of Alginate hydrogel implants into the free wall of the failing LV will reduce LV
size, restore LV shape, lower LV wall stress and improve global LV function.

The Primary Efficacy Endpoint of the study is the change in Peak VO2 (maximum oxygen uptake)
from baseline to 6 months of follow-up. The Primary Safety Endpoint of the study is to
estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device

The hypothesis of the study is that there is a statistically significant difference in change
in Peak VO2 from baseline to 6 month follow-up when the medically managed arm is compared to
the Algisyl-LVR arm, i.e. the Algisyl LVR arm is superior to medical management.
Trial website
https://clinicaltrials.gov/show/NCT01311791
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

Summary results
Other publications