Study of Tadalafil vs. Placebo for Improving Hemodynamics & End-Organ

See also
	Status	Clinical Trial	Phase
	Enrolling by invitation	`NCT02659462` - Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.	N/A
	Completed	`NCT00633815` - Upright Versus Supine Exercise Testing in Fontan-palliated Patients	N/A

See also

Status

Clinical Trial

Phase

Enrolling by invitation

NCT02659462 - Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.

N/A

Completed

NCT00633815 - Upright Versus Supine Exercise Testing in Fontan-palliated Patients

N/A

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	NCT05206955
Study type	Interventional
Source	Mayo Clinic
Contact	ACHD Research Team
Phone	507-293-2565
Email	RSTACHDRESPRG@mayo.edu
Status	Recruiting
Phase	Phase 3
Start date	September 16, 2022
Completion date	February 28, 2027

Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms