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SRD-001 for Heart Failure with Reduced Ejection Fraction

This study is testing a treatment called SRD-001 for people with heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure. HFrEF means your heart's main pumping chamber is too weak to pump enough blood. SRD-001 is a biological treatment that aims to improve how your heart muscle handles calcium, which could make your heart pump better and improve your symptoms. The study is looking for adults aged 18 to 80 who have chronic heart failure, severe symptoms (NYHA class III/IV), and a specific low heart pumping ability (LVEF ≤35%). To see if the treatment is successful, researchers will measure changes in your symptoms and physical abilities over 6 and 12 months. The current status of this study is unclear.

Study design
This study has two parts: an initial open-label (everyone knows what treatment they're getting) Phase 1 with a small number of participants, followed by a larger Phase 2. The Phase 2 part is randomized (like a coin flip decides treatment), double-blind (neither you nor your doctor will know if you're getting SRD-001 or placebo), and plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure changes in symptoms and physical parameters for up to 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04703842

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

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Sardocor Corp.
~57 participants
Updated 2024-03-26 on ClinicalTrials.gov
What's tested:SRD-001Placebo

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in symptomatic parameters
Measured over Baseline to Month 6 and Month 12
+5 more outcomes measured

Conditions

Congestive Heart Failure
Heart Failure, Systolic
Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction

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Heart Failure

NCT04703842

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • San Diego Cardiac Center

    San Diego, Californiastudy coordinator listed

    Recruiting

  • University of California, San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • University of Washington Medicine

    Seattle, Washingtonstudy coordinator listed

    Recruiting

  • Washington University in Saint Louis

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

COO
[email protected]
858-752-2941
Email the study team

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Eligibility criteria

Inclusion

Chronic ischemic or non-ischemic cardiomyopathy
NYHA class III/IV
LVEF ≤35%
Guideline-directed medical therapy for heart failure; ICD

Exclusion

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
Inadequate hepatic and renal function
Diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative

What this trial measures

  • Change from baseline in symptomatic parametersBaseline to Month 6 and Month 12

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

  • Change from baseline in symptomatic parametersBaseline to Month 6 and Month 12

    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

  • Change from baseline in physical parameterBaseline to Month 6 and Month 12

    Distance walked during the 6MWT

  • Change from baseline in LV function/remodelingBaseline to Month 6 and Month 12

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

  • Rate of recurrent eventsBaseline to Month 6 and Month 12

    HF-related hospitalization, ambulatory worsening heart failure, all-cause death, MCSD and transplant

  • Rate of adverse events6 and 12 months

    Treatment-emergent adverse events