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Enzyme Replacement

SRD-001 for Heart Failure (MUSIC-HFrEF1 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Sardocor Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Maximal, optimized heart failure therapy; ICD
Chronic ischemic or non-ischemic cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

MUSIC-HFrEF1 Trial Summary

This trial is testing whether or not fixing a protein that isn't working properly in the heart will help people with heart failure by improving cardiac contractile function (the heart's pumping action) and increasing blood flow.

Who is the study for?
This trial is for adults with heart failure and reduced ejection fraction (LVEF ≤35%). Participants must be in NYHA class III/IV, have an ICD implanted, and be on the best possible heart failure medications. People with poor liver or kidney function, recent cancer treatments (except certain skin cancers), likely need for a heart transplant or mechanical support soon, or specific other heart conditions are not eligible.Check my eligibility
What is being tested?
The study tests whether SRD-001 can improve heart muscle function by correcting calcium handling inside cells. It's compared to a placebo. The idea is that fixing SERCA2a enzyme levels could help hearts pump better and improve blood flow through arteries by aiding vessel relaxation.See study design
What are the potential side effects?
Potential side effects aren't specified here but may include reactions at the injection site, changes in blood pressure or heartbeat due to improved cardiac function, and possibly immune responses if the body reacts to SRD-001 as foreign.

MUSIC-HFrEF1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on the best possible treatment for heart failure and have an ICD.
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I have a long-term heart muscle condition.
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I have a long-term heart muscle condition.
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I am following doctor-recommended treatments for heart failure.
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I have severe heart condition symptoms.

MUSIC-HFrEF1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in LV function/remodeling
Change from baseline in physical parameter
Change from baseline in symptomatic parameters
+2 more
Secondary outcome measures
Concomitant medication use
Incidence of abnormal ECG results
Incidence of abnormal findings from interrogation of implantable cardioverter defibrillator
+3 more

MUSIC-HFrEF1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SRD-001Experimental Treatment1 Intervention
3E13 or 4.5E13 vg; one-time intracoronary infusion
Group II: PlaceboPlacebo Group1 Intervention
One-time intracoronary infusion

Find a Location

Who is running the clinical trial?

Sardocor Corp.Lead Sponsor
2 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Heart Failure
10 Patients Enrolled for Heart Failure
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,759 Total Patients Enrolled
1 Trials studying Heart Failure
49 Patients Enrolled for Heart Failure

Media Library

SRD-001 (Enzyme Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04703842 — Phase 1 & 2
Heart Failure Research Study Groups: Placebo, SRD-001
Heart Failure Clinical Trial 2023: SRD-001 Highlights & Side Effects. Trial Name: NCT04703842 — Phase 1 & 2
SRD-001 (Enzyme Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04703842 — Phase 1 & 2
Heart Failure Patient Testimony for trial: Trial Name: NCT04703842 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots for participants in this experiment?

"Affirmative. Clinicaltrials.gov attests that this medical trial is actively seeking participants since its inception on December 1st, 2021 and most recent update on July 26th 2022. The study aims to involve 56 patients from one single site."

Answered by AI

What are the ultimate objectives of this experiment?

"Sardocor Corp., the trial sponsor, aims to measure Change from baseline in LV function/remodeling over a 6-month and 12-month period. Additionally, they will be tracking secondary outcomes such as New arrhythmias on ECG results, variations in concomitant heart failure medication use, and any abnormalities found during hematologic tests or serum chemistries NT-proBNP troponin evaluations."

Answered by AI

Who is eligible to enroll in the research project?

"This clinical investigation is looking for 56 individuals, aged 18 to 80 years old, who are currently suffering from systolic heart failure."

Answered by AI

What is the highest number of participants that can be included in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this research, initially published on December 1st 2021, is actively enrolling individuals in the experiment. 56 patients must be acquired from a single medical centre."

Answered by AI

Is this clinical experiment enrolling individuals aged 45 or older?

"This research is open to individuals aged eighteen and above, but no more than eighty years old."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Texas Southwestern Medical Center
San Diego Cardiac Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm hoping this clinical trial will help me address my HFpEF. My EF is now 20-25. Trying to optimize my medications at this time. I have had Biventricular pacemaker/ICD since 2007. I am doing everything I can to improve my health. Following diet, exercising 30 minutes every day. Most days my SBP is < 100. I had a L/R Cath in December and do not have any problems with my coronary arteries.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments
~23 spots leftby Dec 2025