Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorSardocor Corp.
About this trial
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:
* safety and tolerability of the gene therapy; and * whether the gene therapy helps the heart ventricles relax during filling. Participants will undergo a one-time infusion of the gene therapy in the cardiac catheterization laboratory and then be followed for safety and effects on left-sided filling pressures while exercising. The first year will have multiple in-person visits followed by 4 years of biannual phone calls.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide informed consent
Negative for anti-AAV1 neutralizing antibodies
NYHA class II or III
Left ventricular ejection fraction ≥ 50%
Disqualifiers
NYHA class IV
Heart failure requiring hospitalization in the past 3 months
Manifested or provocable ischemic heart disease
Atrial fibrillation
Trial design
Design model
Single group
Treatments tested in this trial
AAV1/SERCA2a
Biological/Vaccine3E13 viral genomes fixed dose
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: SRD-001 Gene TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in pulmonary capillary wedge pressure (PCWP)
PCWP assessed by right heart catheterization; change in mmHg from baseline
Time frame
Week 24 and Week 52Secondary outcomes
1
Change in PCWP at 20W exercise
PCWP assessed by right heart catheterization; change in mmHg from baseline
Time frame
Week 24 and Week 522
Change in oxygen uptake (VO2) during exercise
VO2 assessed by bicycle exercise; change in mL/min from baseline
Time frame
Week 24 and Week 523
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 524
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 52Sponsors and contacts
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Source ClinicalTrials.gov