Clinical Trials Logo

Clinical Trial Summary

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of BNP116.sc-CMV.I1c in patients with NYHA Class III heart failure. Patients with symptomatic congestive heart failure will be enrolled until up to 12 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).


Clinical Trial Description

The primary endpoint for this study is safety as measured by the following which will be assessed over the 12 month follow-up period as indicated in the Data Collection Table: - Adverse Events - All-cause Mortality - Heart failure (HF) Hospitalization Secondary Endpoints The secondary safety endpoints assessed will include the following: - Echocardiographic assessments at 4 weeks +/- 3 days post-administration of BNP116.sc-CMV.I1c including - Echocardiographic assessments of LVEF, LVEVD, LVEDVI, VLESV, LVEVI, SpI and GLSand degree of mitral regurgitation o The secondary efficacy endpoints will explore efficacy. Functional endpoints will be assessed as changes from baseline to 6 and 12 months following investigational product administration as indicated. These endpoints include: Functional Status & Hospitalizations - Peak VO2 assessed by cardiopulmonary exercise testing - 6-minute walk test - New York Heart Association (NYHA) Classification - Total number of days alive out-of-hospital (as well as total days out-of-hospital as a % of total days alive post study intervention) Physiologic Assessments at 6 and 12 months compared to baseline - Echocardiographic assessments of LVEF, LVEVD, LVEDVI, VLESV, LVEVI, SpI and GLSand degree of mitral regurgitation - NT-proBNP level Quality of Life at 6 and 12 months compared to baseline o Health related quality of life as assessed by Minnesota Living with Heart Failure Questionnaire (MLWHFQ) The following endpoints will also be measured over the 12 month follow-up period and long-term follow-up period (until month 36 post-intervention): - Survival - Cardiac transplantation - Left ventricular assist device (LVAD) implantation ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04179643
Study type Interventional
Source Asklepios Biopharmaceutical, Inc.
Contact AskBio Medical Affairs
Phone 9195616210
Email askfirst@askbio.com
Status Recruiting
Phase Phase 1
Start date November 20, 2019
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy