Evaluative framework for phase II studies in patients with heart failure and preserved ejection fraction*

JACC: Heart Failure

Volumn 1, Issue 2, 2013, Pages 123-126

  Gheorghiade, Mihai ^a   Vaduganathan, Muthiah ^b   Shah, Sanjiv J ^a  

^a NORTHWESTERN UNIVERSITY   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

Diastolic dysfunction; Heart failure with preserved ejection fraction; Late sodium current inhibition

Indexed keywords

PLACEBO; RANOLAZINE;

CARDIOPULMONARY EXERCISE TEST; CLINICAL STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; ECHOCARDIOGRAPHY; EDITORIAL; HEART EJECTION FRACTION; HEART FAILURE; HEART FAILURE WITH PRESERVED EJECTION FRACTION; HEART HEMODYNAMICS; HEART LEFT VENTRICLE FILLING; HEART OUTPUT; HUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SIDE EFFECT; STUDY DESIGN; TREATMENT DURATION; TREATMENT OUTCOME;

DIASTOLIC DYSFUNCTION; HEART FAILURE WITH PRESERVED EJECTION FRACTION; LATE SODIUM CURRENT INHIBITION;

ACETANILIDES; FEMALE; HEART FAILURE, DIASTOLIC; HUMANS; MALE; PIPERAZINES; SODIUM CHANNEL BLOCKERS;

EID: 84877973822     PISSN: 22131779     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchf.2013.01.001     Document Type: Editorial

References (12)

1. Steinberg B.A., Zhao X., Heidenreich P.A., et al. Trends in patients hospitalized with heart failure and preserved left ventricular ejection fraction: prevalence, therapies, and outcomes. Circulation 2012, 126:65-75.
2. Bhatia R.S., Tu J.V., Lee D.S., et al. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med 2006, 355:260-269.
3. Kitzman D.W., Brubaker P.H., Morgan T.M., et al. Exercise training in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. Circ Heart Fail 2010, 3:659-667.
4. Valdivia C.R., Chu W.W., Pu J., et al. Increased late sodium current in myocytes from a canine heart failure model and from failing human heart. J Mol Cell Cardiol 2005, 38:475-483.
5. Sossalla S., Wagner S., Rasenack E.C., et al. Ranolazine improves diastolic dysfunction in isolated myocardium from failing human hearts. J Mol Cell Cardiol 2008, 45:32-43.
6. Maier L.S., Layug B., Karwatowska-Prokopczuk E., et al. RAnoLazIne for the treatment of diastolic heart failure in patients with preserved ejection fraction: the RALI-DHF proof-of-concept study. J Am Coll Cardiol HF 2013, 1:115-122.
7. Paulus W.J., Tschope C., Sanderson J.E., et al. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J 2007, 28:2539-2550.
8. Gheorghiade M., Pang P.S., O'Connor C.M., et al. Clinical development of pharmacologic agents for acute heart failure syndromes: a proposal for a mechanistic translational phase. Am Heart J 2011, 161:224-232.
9. Solomon S.D., Zile M., Pieske B., et al. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet 2012, 380:1387-1395.
10. Shah S.J., Gheorghiade M. Heart failure with preserved ejection fraction: treat now by treating comorbidities. JAMA 2008, 300:431-433.
11. Shah S.J., Fonarow G.C., Gheorghiade M., Lang R.M. Phase II trials in heart failure: the role of cardiovascular imaging. Am Heart J 2011, 162:3-15.
12. Shah S.J., Heitner J.F., Sweitzer N.K., et al. Baseline characteristics of patients in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial. Circ Heart Fail 2012 Dec 20, [E-pub ahead of print].