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Cancer Vaccine

Genistein for Amyloid Cardiomyopathy (GASPAR Trial)

Phase 1 & 2

Recruiting

Led By Mark JK Chandy, MD PhD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 40-80 years

Heart failure with Reduced Ejection Fraction of ischemic or nonischemic etiology with LVEF <40% by echocardiography, MUGA, or MRI

Must not have

Ethanol abuse: Men >4 drinks on any day or more than 14 drinks per week, Women >3 drinks on any day or more than 7 drinks per week

Uterine fibroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up these parameters will be assessed at baseline (week 0) and with each dose escalation (week 4, week 8, and week 12) and after washout (week 18).

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the safety and effectiveness of genistein in patients with a condition called Transthyretin (TTR) Amyloidosis. The focus is on how genistein

Who is the study for?

This trial is for patients with Transthyretin (TTR) Amyloidosis, specifically affecting the heart. Participants should be able to provide consent and follow the study's procedures, including blood tests, echocardiography, and a walking test. Detailed inclusion and exclusion criteria are not provided.

What is being tested?

The trial is testing genistein's safety and effectiveness in TTR Amyloidosis patients. It involves taking increasing doses of genistein orally over 12 weeks followed by a six-week washout period. The study will measure changes in inflammation markers, cardiac function, and exercise capacity.

What are the potential side effects?

Potential side effects of genistein are not detailed here but may include typical drug-related reactions such as gastrointestinal discomfort or allergic responses. Close monitoring through blood tests aims to ensure patient safety.

Eligibility Criteria

Inclusion Criteria

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

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I am between 40 and 80 years old.

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My heart's pumping ability is weak, with an ejection fraction below 40%.

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My heart failure medications have been stable for 3 months.

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My NT-proBNP levels are above the specified limit for my age group.

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My heart condition is related to ATTR and my heart's pumping ability has been checked.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not drink more than the maximum daily or weekly alcohol limits.

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I have uterine fibroids.

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My liver tests are within normal limits.

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My diabetes is not under control (HgbA1c >10%).

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I have been hospitalized recently, but not for heart failure.

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My heart condition causes no or severe limitations.

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I do not have any current infections or sudden worsening of a long-term infection.

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I am taking thyroid medication.

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My kidney function is very low.

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I have a blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ these parameters will be assessed at baseline (week 0) and with each dose escalation (week 4, week 8, and week 12) and after washout (week 18).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~these parameters will be assessed at baseline (week 0) and with each dose escalation (week 4, week 8, and week 12) and after washout (week 18).

This trial's timeline: 3 weeks for screening, Varies for treatment, and these parameters will be assessed at baseline (week 0) and with each dose escalation (week 4, week 8, and week 12) and after washout (week 18). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiac markers

Complete metabolic profile

Inflammatory markers

Secondary study objectives

The impact of genistein on cardiac diastolic function

The impact of genistein on cardiac function using strain imaging

The impact of genistein on cardiac mass

+3 more

Other study objectives

Exploratory Blood Biomarkers

Microbiome

Microbiome DNA sequencing

+1 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: Genistein Treatment and WashoutExperimental Treatment1 Intervention

The Investigators plan to recruit 40 heart failure participants, including 20 participants with heart failure with reduced ejection fraction (LVEF\<40%) and 20 participants with transthyretin amyloid (ATTR) cardiomyopathy. After an initial telephone call to screen participants, the Investigators will invite qualified people for informed consent and a baseline fasting blood draw. Participants will receive escalating doses of genistein after their baseline fasting blood and stool sample collections. At baseline and again at 3 months, the Investigators will also perform transthoracic echocardiography and a 6-minute walk test.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Genistein

2005

Completed Phase 3

~510

0 / 15Eligibility criteria met