What is the mechanism of action of this treatment?

Common treatments for heart failure often target oxidative stress, inflammation, and mitochondrial dysfunction, which are critical in the pathophysiology of the disease. Agents like antioxidants (e.g., Coenzyme Q10) aim to reduce oxidative damage, while anti-inflammatory drugs help mitigate the chronic inflammation that exacerbates heart failure. Therapies that enhance mitochondrial function, such as certain metabolic modulators, improve energy production and reduce cellular stress. These mechanisms are vital for heart failure patients as they address the underlying cellular dysfunctions, potentially improving cardiac function, reducing symptoms, and enhancing quality of life.

What side effects are associated with this type of intervention?

Common treatments for heart failure that modulate oxidative stress, inflammation, and mitochondrial function include ACE inhibitors, beta-blockers, and antioxidants like Coenzyme Q10. ACE inhibitors can cause side effects such as cough, elevated blood potassium levels, low blood pressure, and kidney dysfunction. Beta-blockers may lead to fatigue, cold extremities, weight gain, and depression. Coenzyme Q10 is generally well-tolerated but can occasionally cause gastrointestinal symptoms like nausea, diarrhea, and loss of appetite. These treatments aim to improve heart function and reduce symptoms but must be monitored for potential adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for heart failure that modulate oxidative stress, inflammation, and mitochondrial function include drugs like beta-blockers (e.g., carvedilol), which reduce oxidative stress and inflammation, and ACE inhibitors (e.g., enalapril), which have anti-inflammatory effects. Additionally, certain antioxidants and anti-inflammatory agents have been explored, but their efficacy in heart failure treatment remains under investigation. While SFN (Sulforaphane) is being studied for its potential benefits in modulating these pathways, it is not yet FDA-approved for heart failure.

What other types of research exist?

Tafamidis is a promising alternative for heart failure patients, particularly those with transthyretin amyloid cardiomyopathy. It has been shown to reduce mortality, cardiovascular-related hospitalizations, and the rate of decline in functional capacity. Tafamidis modulates oxidative stress and inflammation, making it a viable option for heart failure treatment in 2024.

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Phytochemical

Sulforaphane for Heart Failure (CardiacAging Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Texas Tech University Health Sciences Center

Eligibility Criteria Checklist

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

Must have

Age > 60 years

Diagnosis of HFpEF (HF symptoms with a normal EF (>/=50 %)

Must not have

Participants with pulmonary or other issues which restrict walking capacity

On oxygen therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 week

Summary

This trial tests if a broccoli extract called Sulforaphane can help older adults with a certain type of heart failure. The extract may protect the heart by reducing damage and inflammation. Sulforaphane is a compound derived from vegetables like broccoli, known for its anti-inflammatory and antioxidant properties.

Who is the study for?

This trial is for people over 60 with a type of heart failure where the heart muscle pumps well but is stiff (HFpEF). They must be able to walk more than 500 feet and agree not to take any antioxidant supplements during the study. It's not for those who can't consent, have active cancer, don't understand English well enough for the surveys, use oxygen therapy, or have walking issues due to lung or other problems.

What is being tested?

The trial tests if Sulforaphane (SFN), a compound found in vegetables like broccoli, can prevent age-related heart and blood vessel dysfunction. Participants will undergo echocardiograms and exercise endurance tests before and after taking SFN for 24 weeks to see if there's an improvement in their condition.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored closely for any adverse reactions since this study aims to determine how safely SFN can be given at doses that might protect against cardiac dysfunction.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 60 years.

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I have heart failure symptoms but my heart's pumping ability is normal.

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I can walk more than 500 feet by myself.

Exclusion Criteria

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

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I have lung or other health issues that make it hard for me to walk.

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I am currently using oxygen therapy.

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I have been diagnosed with active cancer.

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I am taking antioxidant supplements that are available without a prescription.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 week for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Functional Capacity

cardiac function

Secondary study objectives

Hand grip test

Muscle Function

Other study objectives

DNA damage, CBC, Oxidative stress

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Avmacol ESActive Control1 Intervention

Processed SFN-rich extract will be purchased from Nutramax Laboratories, Inc. 2208 Lakeside Blvd Edgewood, MD 21040. Caplets containing SFN-rich broccoli sprout extracts will be obtained from Nutramax Labs. Study medication will be dispensed in sealed bottles with instructions to keep them in a household freezer. The size of the caplet will be about the size of a 1000 mg Vit C pill (about 2 cm in length). The participants will be dosed, based on weight, in a double-blind fashion with identical appearing placebo or SFN caplets. Participants will be instructed to take a daily dose for 24 weeks based on the participants weight. Two caplets for individuals \<100 lb., three caplets for individuals 100-200 lb. and four caplets for individuals \>200 lb. SFN (Avmacol Extra Strength) will be prescribed by a study physician, and will be dispensed by the study coordinators at TTUHSC Lubbock. Pill counts will be conducted to demonstrate compliance.

Group II: PlaceboPlacebo Group1 Intervention

Placebo caplets containing microcrystalline cellulose will be obtained from Nutramax Labs. Study medication will be dispensed in sealed bottles with instructions to keep them in a household freezer. The size of the caplet will be about the size of a 1000 mg Vit C pill (about 2 cm in length). The participants will be dosed, based on weight, in a double-blind fashion with identical appearing placebo or SFN caplets. Participants will be instructed to take a daily dose for 24 weeks based on the participants weight. Two caplets for individuals \<100 lb., three caplets for individuals 100-200 lb. and four caplets for individuals \>200 lb. Placebo will be prescribed by a study physician, and will be dispensed by the study coordinators at TTUHSC Lubbock. Pill counts will be conducted to demonstrate compliance.

0 / 7Eligibility criteria met

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

Common treatments for heart failure often target oxidative stress, inflammation, and mitochondrial dysfunction, which are critical in the pathophysiology of the disease. Agents like antioxidants (e.g., Coenzyme Q10) aim to reduce oxidative damage, while anti-inflammatory drugs help mitigate the chronic inflammation that exacerbates heart failure. Therapies that enhance mitochondrial function, such as certain metabolic modulators, improve energy production and reduce cellular stress. These mechanisms are vital for heart failure patients as they address the underlying cellular dysfunctions, potentially improving cardiac function, reducing symptoms, and enhancing quality of life.

Urinary Metabolomic Profiling Reveals the Effect of Shenfu Decoction on Chronic Heart Failure in Rats.Metabonomic study of chronic heart failure and effects of Chinese herbal decoction in rats.