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Interventions for Left Ventricular Dysfunction
Phase 4
Recruiting
Led By michael nelson, PhD
Research Sponsored by The University of Texas at Arlington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will enroll healthy men and age-matched healthy premenopausal females to test the hypothesis that cardiac steatosis induced left ventricular dysfunction is sexually dimorphic.
Who is the study for?
Healthy men and premenopausal women with blood pressure under 140/90 mmHg, a BMI of 18.5-30, who exercise less than three times a week, don't smoke or use certain medications that affect cardiovascular function can join. Pregnant women, those planning to become pregnant, individuals with allergies to trial drugs or MRI contraindications are excluded.
What is being tested?
The study is examining how fasting affects heart fat and function differently in men and women. It also looks at whether estrogen protects against heart issues from fat buildup by comparing effects of hormone suppression plus estrogen replacement versus placebo in women.
What are the potential side effects?
Potential side effects may include discomfort from fasting such as dizziness or weakness, reactions to the estradiol patch like skin irritation or hormonal changes, and possible adverse responses to Cetrotide including allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in left ventricular relaxation rate
Comprehensive plasma lipidomics
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Placebo add back with GnRHantExperimental Treatment2 Interventions
Subjects are given placebo patch.
Group II: LBNP OnlyExperimental Treatment1 Intervention
Subjects undergo lower body negative pressure at 40 mmHg.
Group III: Fasting onlyExperimental Treatment1 Intervention
To acutely elevate myocardial triglyceride content, subjects will be asked to abstain from eating for 2 days (reproducibly causes a significant and physiological increase in myocardial fat deposition, transiently). Subjects will be allowed water and/or an isotonic saline solution in order to maintain hydration status.
Group IV: Estrogen add back with GnRHantExperimental Treatment3 Interventions
Subjects are given estradiol patch.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetrotide
2013
Completed Phase 4
~180
Estradiol patch
2019
Completed Phase 1
~530
Find a Location
Who is running the clinical trial?
The University of Texas at ArlingtonLead Sponsor
44 Previous Clinical Trials
4,765 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,080 Previous Clinical Trials
1,056,213 Total Patients Enrolled
michael nelson, PhDPrincipal InvestigatorUniversity of Texas at Arlington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of hormone-sensitive cancer or certain heart, liver, gallbladder, blood clot, high blood fat levels, or unexplained vaginal bleeding conditions.I am not on medications like Levodopa or methotrexate that affect hormone therapy.I have diabetes.Whether the person has a history of smokingYour blood pressure is lower than 140 over 90.You are allergic to the transdermal patch or any of its components, such as cetrorelix or benzyl alcohol.I have a history of seizures or a nervous system condition.I have had a stomach ulcer or bleeding in the past.I currently have an infection.I currently have sepsis.I am not taking any birth control pills, hormone therapies, or medications that could affect my heart.You use illegal drugs, except for occasional marijuana.Your heart's electrical activity at rest is not normal.You cannot have an MRI for medical reasons.You don't exercise vigorously at least 3 days a week.People who do not smoke.Your body mass index (BMI) is between 18.5 and 30.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo add back with GnRHant
- Group 2: Estrogen add back with GnRHant
- Group 3: Fasting only
- Group 4: LBNP Only
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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