FindTrial
Sign In

Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test. [TEMPO-study].

Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test. [TEMPO-study].

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-022389-28-DK
Enrollment
Unknown
Registered
2010-10-26
Start date
2010-11-12
Completion date
Unknown
Last updated
2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a univentricular heart, who have recieved paliating surgery in the form of TCPC operation MedDRA version: 14.1 Level: PT Classification code 10021076 Term: Hypoplastic left heart syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Tracleer Pharmaceutical Form: Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Sponsors

Lars Søndergaard
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: See protocol Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: See protocol

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate if Treatment with an oral endotelinantagonist can improve work capacity in TCPC patients.;Secondary Objective: Other beneficial effects of endotelin treatment in TCPC patients. Reduction of intestinal protein loss, improved quality of life for example. See protocol.;Primary end point(s): See protocol—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026