← Back to Search

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 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

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
45 Previous Clinical Trials
4,808 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,087 Previous Clinical Trials
1,058,952 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
~14 spots leftby Dec 2025