NL-OMON38421
Completed
Phase 2
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) - AUGMENT-HF
oneStar Inc0 sites18 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- heart failure
- Sponsor
- oneStar Inc
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
- •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.
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 midventricular 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;
Outcomes
Primary Outcomes
Not specified
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