Overview

This trial is active, not recruiting.

Condition ischemic heart failure
Treatments placebo, 30 mg dose of jvs-100, 45 mg dose of jvs-100
Phase phase 1/phase 2
Sponsor Juventas Therapeutics, Inc.
Start date October 2013
End date August 2015
Trial size 72 participants
Trial identifier NCT01961726, JTCS-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
30 mg dose of jvs-100
Coronary Sinus Delivery
45 mg dose of jvs-100
Coronary Sinus Delivery
(Experimental)
placebo
Coronary Sinus Delivery
45 mg dose of jvs-100
Coronary Sinus Delivery
(Experimental)
placebo
Coronary Sinus Delivery
30 mg dose of jvs-100
Coronary Sinus Delivery

Primary Outcomes

Measure
Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up
time frame: 4 Months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 - 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 Exclusion Criteria: - 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: - 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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Juventas Therapeutics, Inc..