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Heart FailurePhase 1NCT01082094

Study to Evaluate the Safety of a Single Escalating Dose of ACRX-100 in Adults With Ischemic Heart Failure

A Phase 1 study testing ACRX-100 in people with Heart Failure, run by Juventas Therapeutics, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this Phase 1 study is to assess the safety, tolerability, and preliminary efficacy of single escalating doses of ACRX-100 delivered via endomyocardial injection in adults with ischemic heart failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
ACRX-100
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
4 sitesUnited States
Study dates
Feb 2010to Jan 2012
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Greater than or equal to 18 years of age
  • NYHA Class III
  • Ischemic cardiomyopathy without an acute coronary syndrome within the last 6 months
  • Residual well-demarcated region of LV systolic dysfunction defined as at least 3 consecutive segments of abnormal wall motion by echocardiography read at the echocardiography core laboratory
  • LVEF less than or equal to 40% measured by echocardiography read at the echocardiography core laboratory
  • No left ventricular wall thickness less than 0.5 cm measured by echocardiography read at the echocardiography core laboratory
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  • Mitral regurgitation of 0-2+ (inclusive) measured by echocardiography read at the echocardiography core laboratory
  • Subject has an implanted, functional AICD
  • Subject receiving stable optimal pharmacological therapy defined as:
  • ACE inhibitor and/or ARB, and Beta-blocker for 90 days with stable dose for 30 days unless contraindicate
  • Diuretic in subjects with evidence of fluid retention ASA unless contraindicated
  • Statin unless contraindicated
  • Aldosterone antagonist per physician discretion unless contraindicated
  • Subjects with found diagnosis of diabetes must have had an ophthalmologist exam within the last year showing no active proliferative retinopathy

Who cannot join

  • Planned revascularization within 30 days following enrollment
  • Estimated Glomerular Filtration Rate < 30 ml/min*
  • Inability to undergo SPECT imaging
  • History of aortic valve regurgitation > 2
  • Moderate/Severe aortic stenosis defined as AVA <1.5 cm2
  • Presence of an artificial aortic valve
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  • Subjects with aortic aneurysm >3.8 cm
  • History of cancer with exception of basal cell carcinoma and following results on age appropriate cancer screenings
  • Subjects with persistent atrial fibrillation (per ACC/AHA/ESC guidelines, defined as recurrent AF episodes lasting longer than 7 days)
  • Subjects with Biventricular pacing device implant within the last 3 months OR previously implanted Biventricular pacing device with programming planned to be reoptimized following enrollment in this trial
  • Previous solid organ transplant
  • Subjects with greater than 40% univentricular RV Pacing
  • Subjects with uncontrolled diabetes defined as HbA1c >9.0%
  • Participation in an experimental clinical trial within 30 days prior to enrollment
  • Life expectancy of less than 1 year
  • Positive pregnancy test (serum βHCG) in women of childbearing potential and/or unwillingness to use contraceptives or limit sexual activity
  • Unwillingness of men capable of fathering a child to agree to use barrier contraception or limit sexual activity
  • Subjects who are breast feeding
  • Subjects with a positive test results for hepatitis B/C and/or HIV
  • Total Serum Bilirubin >4.0 mg/dl
  • Aspartate aminotransferase (AST) > 120 IU/L
  • Alanine aminotransferase (ALT) > 135 IU/L
  • Alkaline phosphatase (ALP): >300 IU/L
  • Clinically significant elevations in PT or PTT relative to laboratory norms
  • Proteinuria > 3.5 g/L
  • Any subject with a known existing LV thrombus or has an LV thrombus detected during the screening period of this study. Presence of LV thrombus will be determined by echocardiography and the addition of echo-contrast if any question remains after non-contrast echocardiogram.
  • History of drug or alcohol abuse within the last year
  • A subject will be excluded if he/she is unfit for the trial based on the discretion of the site Principal Investigator
  • Estimated Glomerular Filtration Rate (eGFR) in ml/min is calculated using the subject's serum creatinine value with the following equation : eGFR = 186 x (serum creatinine in mg/dl)-1.154 x (Age)-.2303 x (Age) x (1.210 if subject is black) x (0.742 if subject is female)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Cardiology, PC

    Birmingham, Alabama, 35211

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: An Open Label Dose Escalation Study to Evaluate the Safety of a Single Escalating Dose of ACRX-100 Administered by Endomyocardial Injection to Cohorts of Adults With Ischemic Heart Failure

The purpose of this Phase 1 study is to assess the safety, tolerability, and preliminary efficacy of single escalating doses of ACRX-100 delivered via endomyocardial injection in adults with ischemic heart failure.

Read the detailed description

This open label, 16 subject, Phase 1 dose-escalation study will demonstrate the initial safety of using ACRX-100 to treat heart failure in subjects with ischemic cardiomyopathy. Safety will be tracked at each dose by documenting all adverse events (AEs), with the primary safety endpoint being the number of major cardiac AEs at 30 days. In each cohort (n=4 in low dose, n=6 each in mid and high dose), subjects will receive a single dose of ACRX-100. Preliminary efficacy will be evaluated by measuring the impact on cardiac function via standard echocardiography measurements, cardiac perfusion via SPECT imaging, and improvement in NYHA classification.

Conditions
Heart Failure
Being tested
ACRX-100
Keywords
Ischemic heart failure, Congestive heart failure, Stromal cell-derived factor 1, SDF-1, Gene therapy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACRX-100Biological

    Three cohorts (16 total subjects) will be studied. There will be no concurrent controls. The dose will be escalated by increasing the total amount of ACRX-100 delivered per subject from low dose (n=4 subjects) to middle dose (n=6 subjects) to high dose (n=6 subjects). ACRX-100 will be injected directly into the myocardium as a single dose at multiple sites through a percutaneous, left ventricular approach using a needle injection catheter.

Study groups in NCT01082094
Study groupRoleWhat they receive
ACRX-100ExperimentalCohort 1 = Low dose Cohort 2 = Middle dose Cohort 3 = High Dose
Receives: Biological: ACRX-100

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Major Adverse Cardiac Events (MACE) at 30 days post-injection

    Measured: 30 days post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01082094
Sponsor's protocol ID
JTCS-001
Status last verified
Jun 2012
First submitted
4 Mar 2010
Last updated
6 Jun 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACRX-100 in people with Heart Failure, run by Juventas Therapeutics, Inc. at 4 sites in United States.

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 29 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: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Major Adverse Cardiac Events (MACE) at 30 days post-injection (time frame: 30 days post-injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01082094.

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 6 Jun 2012; AzTrials last refreshed its copy on 5 Nov 2026.

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