A Phase 1 interventional study of AAV1/SERCA2a in Heart Failure, Diastolic and Heart Failure With Preserved Ejection Fraction, sponsored by Sardocor Corp.. Recruiting at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Sardocor Corp. · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to test an experimental gene therapy in participants with heart failure with preserved ejection fraction, also known as diastolic heart failure. The main questions it aims to answer are:
Eligible participants will undergo a one-time antegrade epicardial coronary artery infusion of gene therapy delivered to the 3 major cardiac territories of the left ventricle of the heart (anterior, lateral, inferior/posterior) or bypass grafts unless contraindicated. Post-procedure, the subject will be monitored continuously for a minimum of 4 hours and then discharged to home that same day if medically appropriate. Participants will be followed for 52 weeks as part of the main trial. On Day 2 and Week 1, subjects will be contacted by phone for a general safety assessment, and if clinically indicated, an in-person evaluation and assessment will be performed as soon as possible. On Weeks 2, 4, 12, 24 and 52, subjects will undergo general safety assessments. Additionally, at Weeks 24 and 52, subjects will undergo outpatient core resting and exercise transthoracic echocardiography, right heart catheterization with hemodynamic monitoring and gas exchange measurements, 6-minute wall test, cardiac biomarker testing and completion the Kansas City Cardiomyopathy Questionnaire. Upon completion of the active observation period, participants will continue to be followed for 4 years with bi-annual, semi-structured telephone or in-person questionnaires that collect information on overall status and other comorbid conditions of interest in gene therapy trials.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 10 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Sardocor Corp. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AAV1/SERCA2a 3E13 vg
Biological: AAV1/SERCA2a
3E13 viral genomes fixed dose
Change in pulmonary capillary wedge pressure (PCWP)
PCWP assessed by right heart catheterization; change in mmHg from baseline
Time frame: Week 24 and Week 52
Change in PCWP at 20W exercise
PCWP assessed by right heart catheterization; change in mmHg from baseline
Time frame: Week 24 and Week 52
Change in oxygen uptake (VO2) during exercise
VO2 assessed by bicycle exercise; change in mL/min from baseline
Time frame: Week 24 and Week 52
Change in left ventricular (LV) relaxation
Assessed by transesophageal echocardiography (ultrasound) using 2 methods: LV global peak early diastolic strain rate (1/s) and LV tau
Time frame: Week 24 and Week 52
Change in NT-proBNP
Laboratory measurement (picograms per mL) in blood; high levels indicate the heart is working too hard to pump blood; decrease over time would indicate an improvement in heart failure condition
Time frame: Week 24 and Week 52
Change in left atrial end systolic volume
Assessed by transesophageal echocardiography (ultrasound); change in mL/m2 from baseline
Time frame: Week 24 and Week 52
Change in left atrial reservoir strain
Assessed by transesophageal echocardiography (ultrasound); change in %from baseline
Time frame: Week 24 and Week 52
Change in left atrial contractile strain
Assessed by transesophageal echocardiography (ultrasound); change in % from baseline
Time frame: Week 24 and Week 52
Change in 6 Minute Walk Distance
Distance walked in 6 minutes, measured in meters; the longer distance walked, the better medical condition
Time frame: Week 24 and Week 52
Change in 6 Minute Walk Test Borg scale
Self-rated shortness of breath score with scale from 0 to 10, ranging from none to very, very severe
Time frame: Week 24 and Week 52
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Measures symptoms, physical and social limitations, and quality of life in patients with heart failure; 23-item self-administered questionnaire; score of 0 to 100; 0-24, very poor to poor; 25-49, poor to fair; 50 to 74, faire to good; and 75 to 100, good to excellent
Time frame: Week 24 and Week 52
Change in New York Heart Association class
Classification of heart failure based on severity of symptoms; 4 classes, I, II, III or IV where class I is having no symptoms doing ordinary physical activity; class II is having fatigue, shortness of breath, palpitations or angina with ordinary physical activity; class II is being comfortable only at rest; and class IV is having symptoms even at rest
Time frame: Week 24 and Week 52
Plan to share: No
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Sardocor Corp.