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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 %)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 week

Awards & highlights

CardiacAging Trial Summary

This trial is testing whether a compound called SFN can be safely given to humans in order to protect against age-related heart problems. Benefits will be measured by looking at heart function and exercise endurance before and after the intervention, as well as by looking at various markers in blood cells.

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.Check my eligibility

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.See study design

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.

CardiacAging Trial 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.

CardiacAging Trial 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

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

Primary outcome measures

Functional Capacity

cardiac function

Secondary outcome measures

Hand grip test

Muscle Function

Other outcome measures

DNA damage, CBC, Oxidative stress

CardiacAging 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 / 3Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Texas Tech University Health Sciences CenterLead Sponsor

104 Previous Clinical Trials

10,574 Total Patients Enrolled

2 Trials studying Heart Failure

Media Library

Sulforaphane (Phytochemical) Clinical Trial Eligibility Overview. Trial Name: NCT05408559 — Phase 1 & 2

Heart Failure Research Study Groups: Avmacol ES, Placebo

Heart Failure Clinical Trial 2023: Sulforaphane Highlights & Side Effects. Trial Name: NCT05408559 — Phase 1 & 2

Sulforaphane (Phytochemical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408559 — Phase 1 & 2

Frequently Asked Questions

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

Does this research involve elderly participants?

"The lower bound for age eligibility for this study is 60 years old, whereas the maximum age an individual can be is 80."

Answered by AI

Is it possible to sign up for this clinical trial at this time?

"The clinical trial is still recruiting patients, according to the information available on clinicaltrials.gov. This particular study was posted on 7/1/2022 and last updated on 9/2/2022."

Answered by AI

How many participants can join this clinical trial at most?

"Indeed, the information available on clinicaltrials.gov makes it clear that this trial is still looking for enrollees. Originally posted on July 1st, 2020 and updated September 2nd of the same year, this 200-person study is only being conducted at a single location."

Answered by AI

Who would be an eligible candidate to join this clinical trial?

"The ideal candidate for this clinical trial would be somebody suffering from heart failure, within the age range of 60 to 80 years old. Right now, the research team is looking to enroll around 200 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prevention of Age-associated Cardiac and Vascular Dysfunction Using Avmacol ES

2022. "Prevention of Age-associated Cardiac and Vascular Dysfunction Using Avmacol ES". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05408559.

All > Heart Failure With Preserved Ejection Fraction > Congestive Heart Failure