200 Participants Needed

Sulforaphane for Heart Failure

(CardiacAging Trial)

Sp
PS
Overseen ByPooja Sethi, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Texas Tech University Health Sciences Center
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to avoid taking over-the-counter antioxidant supplements (like vegetable or fruit-containing supplement pills) during the study. It does not specify if you need to stop other medications, so you should discuss this with the trial team.

Is sulforaphane safe for human use?

Sulforaphane, found in broccoli and other cruciferous vegetables, has been studied for its health benefits, including antioxidant effects. While most research has been in animals or lab settings, over 50 clinical trials have examined its safety and effects in humans, suggesting it is generally safe when consumed in typical dietary amounts.12345

How does the drug sulforaphane differ from other treatments for heart failure?

Sulforaphane is unique because it is a natural compound derived from cruciferous vegetables like broccoli and works by reducing oxidative stress and inflammation, which are key factors in heart failure. Unlike many traditional heart failure treatments, sulforaphane's antioxidant properties help improve heart function and prevent damage by boosting the body's own antioxidant defenses.12567

What evidence supports the effectiveness of the treatment Sulforaphane for heart failure?

Research in rabbits shows that Sulforaphane can improve heart function and reduce heart damage by lowering stress and inflammation. Additionally, studies suggest that Sulforaphane, found in broccoli, may have health benefits, including for heart health, due to its ability to activate protective enzymes.138910

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am older than 60 years.
I have heart failure symptoms but my heart's pumping ability is normal.
I can walk more than 500 feet by myself.
See 1 more

Exclusion Criteria

You cannot read and understand the SF-36 questionnaire in English.
I am currently using oxygen therapy.
I have been diagnosed with active cancer.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive Sulforaphane (SFN) or placebo treatment for 24 weeks, with adherence monitored through pill counts

24 weeks
3 visits (in-person) at baseline, 12 weeks, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including echocardiography and exercise tests

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Sulforaphane
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Avmacol ESActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Sulforaphane is already approved in United States for the following indications:

🇺🇸
Approved in United States as Avmacol ES for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials
107
Recruited
11,500+

Published Research Related to This Trial

In a study involving 30 rabbits with chronic heart failure (CHF), treatment with sulforaphane (SFN) significantly improved heart function and structure after 12 weeks, as evidenced by better echocardiographic measurements and reduced heart weight ratios.
SFN treatment reduced markers of oxidative stress and inflammation, such as malondialdehyde (MDA) and inflammatory cytokines, indicating its potential as a therapeutic agent for improving cardiac health in CHF.
Sulforaphane, a Natural Isothiocyanate Compound, Improves Cardiac Function and Remodeling by Inhibiting Oxidative Stress and Inflammation in a Rabbit Model of Chronic Heart Failure.Ma, T., Zhu, D., Chen, D., et al.[2021]
Broccoli consumption, particularly due to the isothiocyanate sulforaphane derived from its precursor glucoraphanin, has been linked to health benefits, including cancer chemoprotection, supported by over 3000 studies and more than 50 clinical trials.
There is a need for improved integration of animal and human studies to better understand the effective doses and mechanisms of action of sulforaphane, as well as to develop reliable biomarkers for its effects in humans.
Broccoli or Sulforaphane: Is It the Source or Dose That Matters?Yagishita, Y., Fahey, JW., Dinkova-Kostova, AT., et al.[2021]
Sulforaphane (SFN) significantly improves the survival of heart cells (cardiomyocytes) under conditions of low oxygen followed by reoxygenation, reducing cell death and apoptosis in a dose-dependent manner.
The protective effects of SFN are linked to the activation of the SIRT1 pathway, which helps inhibit cell death caused by endoplasmic reticulum (ER) stress, suggesting a potential therapeutic mechanism for cardiovascular protection.
Sulforaphane prevents rat cardiomyocytes from hypoxia/reoxygenation injury in vitro via activating SIRT1 and subsequently inhibiting ER stress.Li, YP., Wang, SL., Liu, B., et al.[2021]

Citations

Sulforaphane, a Natural Isothiocyanate Compound, Improves Cardiac Function and Remodeling by Inhibiting Oxidative Stress and Inflammation in a Rabbit Model of Chronic Heart Failure. [2021]
Broccoli or Sulforaphane: Is It the Source or Dose That Matters? [2021]
Sulforaphane prevents rat cardiomyocytes from hypoxia/reoxygenation injury in vitro via activating SIRT1 and subsequently inhibiting ER stress. [2021]
Nutraceutical support in heart failure: a position paper of the International Lipid Expert Panel (ILEP). [2021]
Novel concepts of broccoli sulforaphanes and disease: induction of phase II antioxidant and detoxification enzymes by enhanced-glucoraphanin broccoli. [2021]
Sulforaphane protects H9c2 cardiomyocytes from angiotensin II-induced hypertrophy. [2021]
Sulforaphane: translational research from laboratory bench to clinic. [2021]
Sulforaphane suppresses cardiac hypertrophy by inhibiting GATA4/GATA6 expression and MAPK signaling pathways. [2021]
Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Sulforaphane Attenuates Isoproterenol-Induced Myocardial Injury in Mice. [2021]
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