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Ischemic Heart FailurePhase 2STOP-HFNCT01643590

Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure.

A Phase 2 study testing JVS-100 15 mg dose Injection and JVS-100 30 mg dose injection in people with Ischemic Heart Failure, run by Juventas Therapeutics, Inc. at 16 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, double-blind, placebo controlled Phase II study is designed to assess the safety and efficacy of using JVS-100 to treat heart failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Heart Failure
What is being tested?
JVS-100 15 mg dose Injection and JVS-100 30 mg dose injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
16 sitesUnited States
Study dates
Jul 2012to Nov 2014
Phase
Phase 2
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

  • Willing and able to sign informed consent
  • Greater than or equal to 18 years of age
  • Subjects with impaired 6 minute hall walk distance
  • Impaired quality of life as measured by Minnesota LWHF questionnaire
  • 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
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  • LVEF ≤40% measured by echocardiography read at the echocardiography core laboratory
  • Must meet wall thickness criteria
  • Subject has an implanted, functional AICD
  • Subjects with diabetes must have had an ophthalmologist exam within the last year showing no active proliferative retinopathy
  • 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 contraindicated
  • Diuretic in subjects with evidence of fluid retention
  • ASA unless contraindicated
  • Statin unless contraindicated
  • Aldosterone antagonist per physician discretion

Who cannot join

  • Planned revascularization within 30 days following enrollment
  • Estimated Glomerular Filtration Rate < 30 ml/min*
  • Signs of acute heart failure within 24 hours of scheduled injection
  • History of aortic valve regurgitation classified as "moderate" or severe
  • Moderate/Severe aortic stenosis defined as AVA <1.5 cm2
  • Note: Patient should not be excluded if the patient's medical records document that within the last 6 months the patient has either:
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  • no aortic stenosis
  • mild aortic stenosis
  • normal aortic valve
  • normal aortic pressure gradient
  • aortic pressure gradient < 20 mmHg
  • Presence of an artificial aortic valve
  • Subjects with aortic aneurysm >3.8 cm
  • Mitral regurgitation defined as "severe" measured by echocardiography at the clinical site.
  • Patients with planned mitral valve repair or replacement surgery
  • Any patient with a history of cancer will be excluded unless:
  • The cancer was limited to curable non-melanoma skin malignancies and/or
  • The cancer was removed by a successful tumor resection, with or without radiation or chemotherapy treatment, 5 years or more prior to enrollment in this study without recurrence
  • Subjects must have the following results on age appropriate cancer screenings:
  • Subjects age 50 or older have had a Fecal occult blood test (FOBT) or fecal immunochemical test (FIT) that was negative within the last year
  • Women age 30 or older have had a PAP test that was negative within the last 3 years
  • Women age 40 or older have had a mammogram that was negative within the last year
  • Men above age 45 have had a Prostate-Specific Antigen (PSA) blood test and digital rectal examination (DRE) that was negative within the last year
  • At the request of the site principal investigator, any subject with a non-negative result thought to be due to a non-cancer-related condition will be evaluated by the medical monitor for enrollment
  • Subjects with persistent or chronic atrial fibrillation will be excluded unless:
  • A stable, regular heart rate is maintained with a biventricular pacemaker
  • A stable, regular heart rate is maintained with a univentricular pacemaker pacing less than or equal to 40% of the time
  • 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%
  • Inability to complete 6 minute walk or treadmill exercise test
  • Participation in an experimental clinical trial within 30 days prior to enrollment
  • Any subject who has been enrolled in a gene or stem cell therapy cardiac trial within the last year
  • 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 as described in Section 8.2.1 below
  • Unwillingness of men capable of fathering a child to agree to use barrier contraception or limit sexual activity as described in Section 8.2.1 below
  • 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
  • Any subject with a known existing LV thrombus or has an LV thrombus detected during the screening period of this study.
  • Subjects with Rutherford class 5 or 6 critical limb ischemia
  • Subject with severe chronic obstructive pulmonary disease (COPD)
  • Any subject requiring home oxygen use
  • Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Summa Health System

    Akron, Ohio, 44309

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Cardiology PC

    Birmingham, Alabama, 35211

  • The Lindner Center at the Christ Hospital

    Cincinnati, Ohio, 45238

  • Baylor Healthcare

    Dallas, Texas, 75226

  • Iowa Heart Center

    Des Moines, Iowa, 50026

  • University of Florida

    Gainesville, Florida, 32603

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Columbia University Medical Center

    New York, New York, 10032

  • Montefiore Medical Center

    New York, New York, 10476

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Michigan Cardiovascular Institute

    Saginaw, Michigan, 48601

  • University of Utah

    Salt Lake City, Utah, 84132

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Pepin Heart Institute

    Tampa, Florida, 33613

Other trials in United States

About this study

Official title: A Phase II Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of JVS-100 Administered by Endomyocardial Injection to Cohorts of Adults With Ischemic Heart Failure

This is a randomized, double-blind, placebo controlled Phase II study is designed to assess the safety and efficacy of using JVS-100 to treat heart failure.

Read the detailed description

90 subjects with ischemic cardiomyopathy will be randomized to receive a single dose of 15 or 30 mg of JVS-100 or matching placebo. Subjects will be randomized 1:1:1 to receive either placebo, 15 mg or 30 mg of JVS-100. Subjects will be monitored overnight for 18-24 hours post dose and have scheduled visits at 3 days post-injection for safety evaluations. All subjects will be scheduled for follow-up visits at approximately 30 days (1 month), 120 days (4 months), and 360 days (12 months) to assess safety and cardiac function.

Being tested
JVS-100 15 mg dose Injection, Placebo Injection, JVS-100 30 mg dose injection

What participants receive

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

  • JVS-100 15 mg dose InjectionBiological

    Intramyocardial Injection

  • Placebo InjectionBiological

    Intramyocardial Injection

  • JVS-100 30 mg dose injectionBiological

    Intramyocardial Injection

Study groups in NCT01643590
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo Injection
15 mg dose of JVS-100Experimental15 mg dose of JVS-100
Receives: Biological: JVS-100 15 mg dose Injection
30 mg dose of JVS-100Experimental30 mg dose of JVS-100
Receives: Biological: JVS-100 30 mg dose injection

What is being measured

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

  1. Impact of JVS-100 injection on Six Minute Walk Distance (6MWD) at 4 month follow-up

    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on 6 minute walk distance compared to placebo at 4 months post-dosing

    Measured: 4 Months

  2. Impact of JVS-100 injection on Quality of Life at 4 month follow-up

    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on quality of life measured by the Minnesota Living with Heart Failure Questionnaire compared to placebo at 4 months post-dosing

    Measured: 4 months

Secondary outcomes (7)

  1. Impact of JVS-100 Injection on Quality of Life

    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on quality of life measured by the Minnesota Living with Heart Failure Questionnaire compared to placebo at 12 months post-dosing

    Measured: 12 Months

  2. Impact of JVS-100 Injection on NYHA class

    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on NYHA class compared to placebo at 4 months post-dosing

    Measured: 4 months

  3. Impact of JVS-100 Injection on LVEF

    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on Left Ventricular Ejection Fraction as measured by echocardiography compared to placebo at 4 months post-dosing

    Measured: 4 months

  4. Impact of JVS-100 Injection on Time to First Heart Failure Decompensation

    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the time to first heart failure decompensation compared to placebo

    Measured: Up to 12 months

  5. Impact of JVS-100 Injection on Major Adverse Cardiac Events

    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the number of major adverse cardiac events (MACE) compared to placebo

    Measured: Up to 12 months

  6. Impact of JVS-100 Injection on number of adverse events

    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the number of adverse events compared to placebo

    Measured: Up to 12 months

  7. Impact of JVS-100 Injection on number of serious adverse events

    To investigate the impact of single doses of JVS-100 (either 15 or 30 mg) delivered via endomyocardial injection through the BioCardia Helical Infusion catheter on the number of serious adverse events compared to placebo

    Measured: Up to 12 months

Timeline

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

  1. First posted18 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionOct 2014 (estimated)
  4. Study completionNov 2014 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01643590
Sponsor's protocol ID
JTCS-004
Acronym
STOP-HF
Status last verified
Feb 2014
First submitted
10 Jul 2012
Last updated
7 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JVS-100 15 mg dose Injection and JVS-100 30 mg dose injection in people with Ischemic Heart Failure, run by Juventas Therapeutics, Inc. at 16 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 16 inclusion and 51 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: status not confirmed, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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?

Impact of JVS-100 injection on Six Minute Walk Distance (6MWD) at 4 month follow-up (time frame: 4 Months). The study lists 2 primary outcomes in all. 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 NCT01643590.

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 7 Feb 2014.

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