- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01961726
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure (RETRO-HF)
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35211
- Cardiology, P.C.
-
-
Florida
-
Gainsville, Florida, Förenta staterna, 32610-0277
- University of Florida
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna, 45219
- The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84132
- University of Utah
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Placebo
|
Coronary Sinus Delivery
Coronary Sinus Delivery
|
Experimentell: 30 mg dose of JVS-100
|
Coronary Sinus Delivery
Coronary Sinus Delivery
|
Experimentell: 45 mg dose of JVS-100
|
Coronary Sinus Delivery
Coronary Sinus Delivery
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up
Tidsram: 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.
|
4 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Impact of JVS-100 delivery on heart failure symptoms compared to placebo at 4 and/or 12 month follow-up
Tidsram: 4 and/or 12 months
|
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.
|
4 and/or 12 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Impact of JVS-100 delivery on quality of life measure at 4 month follow-up
Tidsram: 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 quality of life measure compared to placebo at 4 months post dosing.
|
4 Months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- JTCS-003
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