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Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction

ConditionsCongestive Heart FailureHeart Failure, SystolicHeart FailureHFrEF - Heart Failure With Reduced Ejection Fraction
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSardocor Corp.

About this trial

It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chronic ischemic or non-ischemic cardiomyopathy

NYHA class III/IV

LVEF ≤35%

Guideline-directed medical therapy for heart failure; ICD

Disqualifiers

Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm

Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), mechanical circulatory support device (MCSD) or cardiac shunt

Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment

Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability

Trial design

Design model

Parallel

Treatments tested in this trial

  • SRD-001

    Biological/Vaccine

    AAV1/SERCA2a

  • Placebo

    Drug

    SRD-001 matching placebo

Treatment groups

57 Participants
are divided into 2 treatment groups
Group A: SRD-001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in symptomatic parameters

New York Heart Association classification (I, II, III or IV)

Time frame
Baseline to Month 6 and Month 12
2

Change from baseline in symptomatic parameters

Quality of life as assessed by Kansas City Cardiomyopathy Questionnaire: 0-24, very poor to poor; 25-49, poor to fair; 50-74, fair to good; and 75-100, good to excellent

Time frame
Baseline to Month 6 and Month 12
3

Change from baseline in physical parameter

Distance walked during the 6MWT

Time frame
Baseline to Month 6 and Month 12
4

Change from baseline in LV function/remodeling

Left ventricular end systolic volume (LVESV) as assessed by echocardiography

Time frame
Baseline to Month 6 and Month 12

Secondary outcomes

1

Proportion of subjects who complete the trial

Those who complete the trial vs withdraw consent, are lost to follow-up, or withdrawn due to an AE or other reason

Time frame
12 months
2

Concomitant medication use

Changes in heart failure related medications

Time frame
6 and 12 months
3

Incidence of abnormal laboratory test results

Hematologic, serum chemistries, NT-proBNP and troponin

Time frame
Baseline to Month 6 and Month 12
4

Incidence of abnormal ECG results

New arrhythmias

Time frame
Baseline to Month 6 and Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sardocor Corp.

Lead sponsor

Source ClinicalTrials.gov
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