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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 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
Change in left ventricular relaxation rate
Comprehensive plasma lipidomics

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
43 Previous Clinical Trials
4,838 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,048 Previous Clinical Trials
1,053,675 Total Patients Enrolled
michael nelson, PhDPrincipal InvestigatorUniversity of Texas at Arlington

Media Library

Fasting Clinical Trial Eligibility Overview. Trial Name: NCT04671966 — Phase 4
Heart Disease Research Study Groups: Placebo add back with GnRHant, Estrogen add back with GnRHant, Fasting only, LBNP Only
Heart Disease Clinical Trial 2023: Fasting Highlights & Side Effects. Trial Name: NCT04671966 — Phase 4
Fasting 2023 Treatment Timeline for Medical Study. Trial Name: NCT04671966 — Phase 4

Frequently Asked Questions

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

Is the recruitment phase of this trial still open to participants?

"As indicated on the clinicaltrials.gov site, this medical study is actively recruiting individuals to participate. The trial was originally posted in September 2018 and recently updated in March 2022."

Answered by AI

Does this trial extend to individuals over forty years of age?

"According to the entry requirements for this clinical trial, individuals aged 18-30 are eligible. Additionally, separate research studies involving younger and older participants (under 18 and over 65 respectively) have been conducted with 111 and 496 persons participating accordingly."

Answered by AI

Am I qualified to take part in this research study?

"This clinical trial is searching for 100 people between the ages of 18 and 30 who have left ventricular dysfunction. As well, these individuals must satisfy additional criteria such as having a BMI ranging from 18.5 to 30 kg/m2; being either sedentary or recreationally active (with no more than 3 days of strenuous aerobic exercise each week); not using oral contraceptives hormone therapy, or any other medications that could affect cardiovascular function; and finally, they must be non-smokers."

Answered by AI

How many participants are currently undergoing treatment in this experiment?

"Affirmative, clinicaltrials.gov data suggests that this medical research program is actively enrolling participants. The study was first listed on September 13th 2018 and has had its details updated most recently in March 10th 2022. A hundred prospective patients are sought from a single site."

Answered by AI

Is there any approval from the FDA for fasting regimens?

"Based on the Phase 4 trial data, our team has determined that fasting presents a moderate to high level of safety with a score of 3."

Answered by AI

What is the conventional application of Fasting as a form of therapy?

"Amenorrhea, estrogen deficiency, and hot flashes can be alleviated with Fasting."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction
2018. "Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04671966.
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~9 spots leftby Dec 2024
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