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Assessment Arm for Fontan Circulation (IMPROVE-FALD Trial)

Phase 1

Recruiting

Led By Jonathan Wagner, DO

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

IMPROVE-FALD Trial Summary

"This trial will study how liver congestion and fibrosis affect how drugs are processed in the liver in young patients with Fontan circulation."

Who is the study for?

This trial is for children, adolescents, and young adults with a unique heart condition called Single Ventricle Heart and Fontan Circulation who also have liver disease. Specific eligibility details are not provided but typically include certain age ranges and health status requirements.Check my eligibility

What is being tested?

The study is testing the effects of two medications, Sildenafil (in doses depending on weight) and Pravastatin (doses vary by age), on how the liver processes drugs in patients with Fontan circulation-related liver issues.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones for Sildenafil may include headaches, flushing, stomach discomfort; Pravastatin might cause muscle pain, digestive problems or changes in liver enzymes.

IMPROVE-FALD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pravastatin concentration as measured by area under the curve (AUC)

Sildenafil concentration as measured by area under the curve (AUC)

IMPROVE-FALD Trial Design

1Treatment groups

Experimental Treatment

Group I: Assessment ArmExperimental Treatment2 Interventions

Assessment group will receive a single dose of oral sildenafil and oral pravastatin.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana Clinical and Translational Sciences InstituteOTHER

19 Previous Clinical Trials

4,658 Total Patients Enrolled

Children's Mercy Hospital Kansas CityLead Sponsor

245 Previous Clinical Trials

935,784 Total Patients Enrolled

Jonathan Wagner, DOPrincipal InvestigatorChildren's Mercy

Frequently Asked Questions

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

What is the current number of individuals enrolled in this research investigation?

"Affirmative. The particulars on clinicaltrials.gov demonstrate that this investigation is actively seeking potential participants. Originally shared on March 1, 2024, and most recently revised on March 20, 2024, the trial aims to recruit a total of 15 individuals at one designated site."

Answered by AI

Are new participants currently being sought for this medical study?

"Affirmative, the details on clinicaltrials.gov indicate an ongoing search for participants in this investigation. The trial was first made public on March 1st, 2024 and had its latest update on March 20th, 2024. Enrollment targets include recruiting a total of 15 individuals at one designated site."

Answered by AI

Has the Assessment Arm been granted approval by the FDA?

"Assessment Arm has been assigned a safety rating of 1 by our team at Power on the scale from 1 to 3. This evaluation is due to its Phase 1 trial status, indicating scarce evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease

Jon Wagner 2024. "IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06324396.

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