- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35211
- Cardiology, P.C.
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Florida
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Gainsville, Florida, États-Unis, 32610-0277
- University of Florida
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
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Utah
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Salt Lake City, Utah, États-Unis, 84132
- University of Utah
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
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Coronary Sinus Delivery
Coronary Sinus Delivery
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Expérimental: 30 mg dose of JVS-100
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Coronary Sinus Delivery
Coronary Sinus Delivery
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Expérimental: 45 mg dose of JVS-100
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Coronary Sinus Delivery
Coronary Sinus Delivery
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up
Délai: 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.
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4 Months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Impact of JVS-100 delivery on heart failure symptoms compared to placebo at 4 and/or 12 month follow-up
Délai: 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.
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4 and/or 12 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Impact of JVS-100 delivery on quality of life measure at 4 month follow-up
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JTCS-003
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