Ischemic Heart FailurePhase 1/2RETRO-HFNCT01961726
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure
A Phase 1/2 study testing 30 mg dose of JVS-100 and 45 mg dose of JVS-100 in people with Ischemic Heart Failure, run by Juventas Therapeutics, Inc. at 4 sites in United States.
Trial summary
A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde delivery to cohorts of adults with Ischemic 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?
- 30 mg dose of JVS-100 and 45 mg dose of JVS-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2013to Aug 2015
- Phase
- Phase 1/2
- 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
- Poor quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ)
- Impaired 6 Minute Walk test
- 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 less than or equal to 40% measured by echocardiography read at the echocardiography core laboratory
- 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
- Subject must not have a permanent device placed in the coronary sinus at the time of enrollment *As defined as no more than 50% change in dose
Who cannot join
- Planned revascularization within 30 days following enrollment
- Note: if an angiographic study has been performed within the last year and the subject is enrolled, the angiography study report should be included as part of the subject's file
- Estimated Glomerular Filtration Rate < 30 ml/min*
- Signs of acute heart failure within 24 hours of scheduled infusion
- History of aortic valve regurgitation classified as "moderate-severe" or worse
- Patients will be excluded who have:
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- Known prior trauma to the coronary sinus
- In dwelling instrumentation that may hamper coronary venous catheterization, including a biventricular pacing coronary sinus lead
- 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 with persistent (per ACC/AHA/EEC guidelines)53, defined as recurrent AF episodes lasting longer than 7 days) 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
- Inability to undergo 6 minute walk or treadmill exercise test
- Previous solid organ transplant
- Subjects with greater than 40% univentricular RV Pacing
- Subjects with uncontrolled diabetes defined as HbA1c >10 %
- 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 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 will be excluded unless:
- The subject is a carrier for hepatitis B/C but has never had an active flare
- Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
- 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 at day 0
- Critical limb ischemia that limits the patients from completing 6 minute walk or treadmill testing
- Subjects with severe chronic obstructive pulmonary disease (COPD)
- Severe defined as having been hospitalized for COPD within the last 12 months
- Any subject requiring home oxygen use for treatment of the symptoms of COPD
- 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
4 sites in 1 country.
United States4 sites
Cardiology, P.C.
Birmingham, Alabama, 35211
The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219
University of Florida
Gainsville, Florida, 32610-0277
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: A Phase I/II Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Retrograde Delivery to Cohorts of Adults With Ischemic Heart Failure
A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde delivery to cohorts of adults with Ischemic Heart Failure.
Read the detailed description
72 subjects with ischemic cardiomyopathy. The Phase I portion (n=12 subjects) will be open label. In the first cohort, six subjects will receive a single dose of 30 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 1, a safety assessment by the DSMC will be performed. Upon DSMC approval, the second cohort of six subjects will receive a single dose of 45 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 2, a safety assessment by the DSMC will be performed. Upon DSMC approval, up to 60 subjects will be randomized (1:1:1) to receive a single dose of 30 mg or 45 mg of JVS-100 or matching placebo.
- Conditions
- Ischemic Heart Failure
- Being tested
- Placebo, 30 mg dose of JVS-100, 45 mg dose of JVS-100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Coronary Sinus Delivery
30 mg dose of JVS-100Biological
Coronary Sinus Delivery
45 mg dose of JVS-100Biological
Coronary Sinus Delivery
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Biological: 30 mg dose of JVS-100; Biological: 45 mg dose of JVS-100 |
| 30 mg dose of JVS-100 | Experimental | Not described Receives: Biological: Placebo; Biological: 45 mg dose of JVS-100 |
| 45 mg dose of JVS-100 | Experimental | Not described Receives: Biological: Placebo; Biological: 30 mg dose of JVS-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up
To investigate the impact of single doses of JVS-100 (either 30 or 45 mg) delivered retrograde via the coronary sinus through the Oscor Venos Occlusion Balloon catheter on 6 minute walk distance compared to placebo at 4 months post dosing.
Measured: 4 Months
Secondary outcomes (1)
Impact of JVS-100 delivery on heart failure symptoms compared to placebo at 4 and/or 12 month follow-up
To assess the impact of a single dose of JVS-100 on heart failure symptoms compared to placebo at 4 and/or 12 months post-dosing.
Measured: 4 and/or 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juventas Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961726
- Sponsor's protocol ID
- JTCS-003
- Acronym
- RETRO-HF
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2013
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Retrograde Delivery to Cohorts of Adults With Ischemic Heart Failure
- ClinicalTrials.gov ID
- NCT01961726
- Acronym / sponsor ID
- RETRO-HF / JTCS-003
- Conditions
- Ischemic Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Juventas Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase I/II study to evaluate the safety and efficacy of JVS-100 administered by retrograde delivery to cohorts of adults with Ischemic Heart Failure.
Detailed description
72 subjects with ischemic cardiomyopathy. The Phase I portion (n=12 subjects) will be open label. In the first cohort, six subjects will receive a single dose of 30 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 1, a safety assessment by the DSMC will be performed. Upon DSMC approval, the second cohort of six subjects will receive a single dose of 45 mg of JVS-100 with a minimum of 3 days between each enrollment. After seven days following the enrollment of the last patient of cohort 2, a safety assessment by the DSMC will be performed. Upon DSMC approval, up to 60 subjects will be randomized (1:1:1) to receive a single dose of 30 mg or 45 mg of JVS-100 or matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: 30 mg dose of JVS-100, Biological: 45 mg dose of JVS-100 |
| 30 mg dose of JVS-100 | Experimental | Biological: Placebo, Biological: 45 mg dose of JVS-100 |
| 45 mg dose of JVS-100 | Experimental | Biological: Placebo, Biological: 30 mg dose of JVS-100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing and able to sign informed consent
- Greater than or equal to 18 years of age
- Poor quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ)
- Impaired 6 Minute Walk test
- Ischemic cardiomyopathy without an acute coronary syndrome within the last 6 months
Key exclusion criteria (39 listed)
- Planned revascularization within 30 days following enrollment
- Estimated Glomerular Filtration Rate < 30 ml/min*
- Signs of acute heart failure within 24 hours of scheduled infusion
- History of aortic valve regurgitation classified as "moderate-severe" or worse
- Patients will be excluded who have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboCoronary Sinus Delivery | Biological | 30 mg dose of JVS-100, 45 mg dose of JVS-100 |
| 30 mg dose of JVS-100Coronary Sinus Delivery | Biological | 45 mg dose of JVS-100, Placebo |
| 45 mg dose of JVS-100Coronary Sinus Delivery | Biological | 30 mg dose of JVS-100, Placebo |
Primary outcome
Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up
Time frame: 4 Months
To investigate the impact of single doses of JVS-100 (either 30 or 45 mg) delivered retrograde via the coronary sinus through the Oscor Venos Occlusion Balloon catheter on 6 minute walk distance compared to placebo at 4 months post dosing.
1 secondary outcome
Impact of JVS-100 delivery on heart failure symptoms compared to placebo at 4 and/or 12 month follow-up
Time frame: 4 and/or 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 30 mg dose of JVS-100 and 45 mg dose of JVS-100 in people with Ischemic 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 15 inclusion and 39 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 23 Oct 2014. 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. 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 combined 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.
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 delivery on 6 minute walk distance at 4 month follow-up (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2014.