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Gene Therapy

Gene Therapy for Diastolic Heart Failure (MUSIC-HFpEF Trial)

Phase 1
Recruiting
Research Sponsored by Sardocor Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NYHA class II or III
On oral diuretic therapy
Must not have
NYHA class IV
Heart failure requiring hospitalization in the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24 and week 52
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new gene therapy for people with a type of heart failure where the heart struggles to relax and fill with blood. The therapy is given through an infusion directly into the heart. Researchers want to see if it helps the heart work better and if it is safe for patients. Gene therapy has shown promise in treating heart failure, with improvements making it safer and more effective.

Who is the study for?
This trial is for adults with heart failure who still have a good amount of pumping function (ejection fraction ≥ 50%) and symptoms that are not the most severe. They should be able to exercise somewhat, take diuretics, and use birth control if needed. People with severe lung disease, extreme obesity, unstable conditions, major organ dysfunction or specific heart diseases like amyloidosis can't join.
What is being tested?
The study tests a one-time gene therapy infusion called AAV1/SERCA2a to see if it's safe and can help the heart fill better during relaxation. Participants will receive this treatment in a special lab setting and then be monitored closely for one year with follow-ups over phone calls for four more years.
What are the potential side effects?
Potential side effects may include reactions at the infusion site or allergic responses due to the body's reaction to the new gene material. Since it involves genetic therapy, there might also be unforeseen risks related to altering genes within heart muscle cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart condition mildly or moderately affects my daily activities.
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I am currently taking water pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart condition severely limits my physical activity.
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I was hospitalized for heart failure in the last 3 months.
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I have a heart valve problem on the left side that hasn't been treated.
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I have severe chronic obstructive pulmonary disease.
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I have atrial fibrillation.
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I have heart disease that shows symptoms or can be triggered.
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I was diagnosed with cancer within the last 5 years.
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I have a history of amyloidosis.
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I have severe liver, kidney, or blood problems.
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I have a history of specific heart or thyroid conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in pulmonary capillary wedge pressure (PCWP)
Secondary study objectives
Change in 6 Minute Walk Distance
Change in 6 Minute Walk Test Borg scale
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SRD-001 Gene TherapyExperimental Treatment1 Intervention
AAV1/SERCA2a 3E13 vg

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Gene therapy for heart failure, such as the one being studied to improve ventricular relaxation, works by modifying genetic material to enhance the function of proteins involved in cardiac muscle contraction and relaxation. This can help the heart fill more effectively during diastole, improving overall cardiac function. Other common treatments include inotropes, which increase the force of heart contractions, and vasodilators, which reduce the resistance the heart must pump against, thereby improving blood flow and reducing the heart's workload. Mechanical support devices, like ventricular assist devices, can take over some of the heart's pumping function, providing relief to the failing heart. These treatments are crucial for heart failure patients as they aim to improve symptoms, enhance quality of life, and reduce the risk of hospitalization and mortality.

Find a Location

Who is running the clinical trial?

Sardocor Corp.Lead Sponsor
2 Previous Clinical Trials
69 Total Patients Enrolled
1 Trials studying Heart Failure
57 Patients Enrolled for Heart Failure
~3 spots leftby Aug 2025
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