NCT01454128 - 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)

Bradley TD, Logan AG, Kimoff RJ, Sériès F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators
Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33.
Corrà U, Pistono M, Mezzani A, Braghiroli A, Giordano A, Lanfranchi P, Bosimini E, Gnemmi M, Giannuzzi P
Sleep and exertional periodic breathing in chronic heart failure: prognostic importance and interdependence. Circulation. 2006 Jan 3;113(1):44-50. Epub 2005 Dec 27.
Francis DP, Davies LC, Piepoli M, Rauchhaus M, Ponikowski P, Coats AJ
Origin of oscillatory kinetics of respiratory gas exchange in chronic heart failure. Circulation. 1999 Sep 7;100(10):1065-70.
Leite JJ, Mansur AJ, de Freitas HF, Chizola PR, Bocchi EA, Terra-Filho M, Neder JA, Lorenzi-Filho G
Periodic breathing during incremental exercise predicts mortality in patients with chronic heart failure evaluated for cardiac transplantation. J Am Coll Cardiol. 2003 Jun 18;41(12):2175-81.
Yajima T, Koike A, Sugimoto K, Miyahara Y, Marumo F, Hiroe M
Mechanism of periodic breathing in patients with cardiovascular disease. Chest. 1994 Jul;106(1):142-6.

The Role of Exercise-Periodic-Breathing in Impaired Ventilation Regulation Dysfunction in Patients With Heart Failure

Clinical trial NCT01454128 - References