IMProving DRug Dosing & Outcomes for Single VEntricle Patients With Fontan

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06258382` - Fontan Circulation and Reproductive Health in a National Swedish Cohort
Not yet recruiting	`NCT06197763` - Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation.	Phase 1/Phase 2
Completed	`NCT00964782` - The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation	Phase 4

See also

Status

Clinical Trial

Phase

Recruiting

NCT06258382 - Fontan Circulation and Reproductive Health in a National Swedish Cohort

Not yet recruiting

NCT06197763 - Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation.

Phase 1/Phase 2

Completed

NCT00964782 - The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

Phase 4

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT06324396
Study type	Interventional
Source	Children's Mercy Hospital Kansas City
Contact	Jonthan Wagner, DO
Phone	816-731-7240
Email	jbwagner@cmh.edu
Status	Recruiting
Phase	Phase 1
Start date	March 1, 2024
Completion date	December 31, 2025

IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease — IMPROVE-FALD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms