A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure

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Brief Title

A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure

Official Title

A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure

Brief 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.

      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 Type

Interventional


Primary Outcome

Peak VO2

Secondary Outcome

 NYHA Functional Class

Condition

Heart Failure

Intervention

Algisyl

Study Arms / Comparison Groups

 Algisyl
Description:  Algisyl device (implants) administered during a surgical procedure.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

240

Start Date

August 2017

Completion Date

January 2024

Primary Completion Date

January 2020

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

             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.

          4. 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

          5. 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.

          6. 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)

          7. 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)

          8. 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.

          9. 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

         10. 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 presenting with a restrictive cardiomyopathy such as due to amyloidosis,
             sarcoidosis, or hemochromatosis

          4. Patient with a history of constrictive pericarditis

          5. Patients with a Q wave myocardial infarction (MI) within the last 30 days

          6. Patients with a recent history of stroke (within 60 days prior to the surgical
             procedure)

          7. 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)

          8. Patients with an estimated glomerular filtration rate (GFR) < 30 mL/min/1.73 m2

          9. Clinically significant liver enzyme abnormalities, i.e., AST(SGOT) and ALT (SGPT) more
             than 2.5 times the upper limit of normal

         10. History of severe COPD (i.e., FEV 1< 1 liter or FEV1 < 50% predicted)

         11. 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

         12. 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
      

Gender

All

Ages

18 Years - 79 Years

Accepts Healthy Volunteers

No

Contacts

, 949-679-6185, [email protected]



Administrative Informations


NCT ID

NCT03082508

Organization ID

LSH-14-001


Responsible Party

Sponsor

Study Sponsor

LoneStar Heart, Inc.


Study Sponsor

, , 


Verification Date

March 2017