MedTrace Logo

Theophylline Effects in the Fontan Circulation

NCT05717049 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-09-21

No results posted yet for this study

Summary

A single group treatment phase 2 single-arm no-masking study to assess safety and efficacy of a short-term oral treatment with theophylline (ATC-no. R03D A04) in terms of improvements in cardiorespiratory fitness, health-related quality of life, cardiac performance and respiratory function in male and female adolescents aged 16 to 25 years with a Fontan-type surgical palliation of univentricular congenital heart disease.

Conditions

  • Congenital Heart Disease

Interventions

DRUG

Theophylline Tablets

12 week oral treatment

Sponsors & Collaborators

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • Norwegian Health Association

    collaborator OTHER

  • Norwegian Association for Children with Congenital Heart Disease

    collaborator UNKNOWN

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Thomas Möller, MD PhD · Oslo University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-09
Primary Completion
2023-09-15
Completion
2023-09-15

Countries

  • Norway

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717049 on ClinicalTrials.gov