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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24 and week 52

Awards & highlights

MUSIC-HFpEF Trial Summary

This trial tests a gene therapy to help people with diastolic heart failure. Participants get a one-time infusion and follow-up for safety and changes in heart function. Long-term follow-up includes yearly in-person visits and biannual phone calls.

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.Check my eligibility

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.See study design

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.

MUSIC-HFpEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart condition mildly or moderately affects my daily activities.

Select...

I am currently taking water pills.

MUSIC-HFpEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24 and week 52

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in pulmonary capillary wedge pressure (PCWP)

Secondary outcome measures

Change in 6 Minute Walk Distance

Change in 6 Minute Walk Test Borg scale

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score

+8 more

MUSIC-HFpEF Trial Design

1Treatment groups

Experimental Treatment

Group I: SRD-001 Gene TherapyExperimental Treatment1 Intervention

AAV1/SERCA2a 3E13 vg

0 / 2Eligibility criteria met

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

Frequently Asked Questions

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

Has the SRD-001 Gene Therapy achieved regulatory consent?

"Taking into consideration the limited evidence available, our team at Power rated SRD-001 Gene Therapy with a score of 1 on safety. This evaluation is based on its Phase 1 clinical trial status which suggests minimal data supporting efficacy and security."

Answered by AI

How many participants are being researched in this investigation?

"Affirmative. Per the information provided on clinicaltrials.gov, participants are presently being recruited for this medical trial which was originally posted on August 24th 2023 and last modified on September 23rd 2023. The research calls for 10 patients across 2 locations."

Answered by AI

Are individuals able to join this research project at the present moment?

"Indeed, the data hosted on clinicaltrials.gov states that this research initiative is actively seeking applicants. It was launched on August 24th 2023 and most recently edited on September 23rd of the same year. A total of 10 participants will be accepted between two select medical centres."

Answered by AI