NCT03050112 - Clinical Trial References

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.

Citation(s)

Apers S, Luyckx K, Moons P
Quality of life in adult congenital heart disease: what do we already know and what do we still need to know? Curr Cardiol Rep. 2013 Oct;15(10):407. doi: 10.1007/s11886-013-0407-x. Review.
Dixon T, Lim LL, Oldridge NB
The MacNew heart disease health-related quality of life instrument: reference data for users. Qual Life Res. 2002 Mar;11(2):173-83.
Fteropoulli T, Stygall J, Cullen S, Deanfield J, Newman SP
Quality of life of adult congenital heart disease patients: a systematic review of the literature. Cardiol Young. 2013 Aug;23(4):473-85. doi: 10.1017/S1047951112002351. Epub 2013 Feb 6. Review.
Höfer S, Lim L, Guyatt G, Oldridge N
The MacNew Heart Disease health-related quality of life instrument: a summary. Health Qual Life Outcomes. 2004 Jan 8;2:3.
Immer FF, Althaus SM, Berdat PA, Saner H, Carrel TP
Quality of life and specific problems after cardiac surgery in adolescents and adults with congenital heart diseases. Eur J Cardiovasc Prev Rehabil. 2005 Apr;12(2):138-43.
Lane DA, Lip GY, Millane TA
Quality of life in adults with congenital heart disease. Heart. 2002 Jul;88(1):71-5.
Pavy B, Iliou MC, Höfer S, Vergès-Patois B, Corone S, Aeberhard P, Curnier D, Henry J, Ponchon-Weess A, Oldridge N
Validation of the French version of the MacNew heart disease health-related quality of life questionnaire. Arch Cardiovasc Dis. 2015 Feb;108(2):107-17. doi: 10.1016/j.acvd.2014.09.006. Epub 2014 Nov 12.
Wauthy P, Massaut J, Sanoussi A, Demanet H, Morissens M, Damry N, Dessy H, Malekzadeh-Milani SG, Deuvaert FE
Ten-year experience with surgical treatment of adults with congenital cardiac disease. Cardiol Young. 2011 Feb;21(1):39-45. doi: 10.1017/S1047951110001332. Epub 2010 Oct 6.

Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.

Details for clinical trial NCT03050112

Clinical trial NCT03050112 - References