O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Piña IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50.
HF-ACTION was a multicenter, randomized controlled trial of 2,331 medically stable outpatients with heart failure and reduced ejection fraction conducted at 82 centers across the U.S., Canada, and France. It was the first large-scale randomized trial to examine a regular, structured, exercise intervention in a patient population with chronic heart failure. This publication presented the primary outcomes of the study, which showed modest significant reductions in the primary endpoints of all-cause mortality or hospitalization after adjustment for highly prognostic predictors of these endpoints. (PDF)
Whellan DJ, Ousdigian KT, Al-Khatib SM, Pu W, Sarkar S, Porter CB, Pavri BB, O’Connor CM; PARTNERS Study Investigators. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations; results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. J Am Coll Cardiol 2010 Apr 27;55(17):1803-10.
The PARTNERS-HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study investigated the ability of diagnostics from implantable devices to predict clinical heart failure events. The trial resulted in the identification of specific device diagnostic parameters that successfully identified patients at higher risk for heart failure events within 30 days. (PDF)
Whellan DJ, Goldstein JL, Cryer BL, Eisen GM, Lanas A, Miller AB, Scheiman JM, Fort JG, Zhang Y, O'Connor C. PA32540 (a coordinated-delivery tablet of enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) versus enteric-coated aspirin 325 mg alone in subjects at risk for aspirin-associated gastric ulcers: results of two 6-month, phase 3 studies. Am Heart J. 2014 Oct;168(4):495-502.e4.
While aspirin has been established as a mainstay of treatment in the secondary prevention of cardiovascular disease for many years, certain sub-populations, such as older patients and those with a history of gastric ulcer, may be at a higher risk of bleeding and gastrointestinal side effects with daily use. This clinical trial compared a novel coordinated-delivery tablet of 325 mg enteric-coated aspirin and 40 mg immediate-release omeprazole with a control of 325 mg enteric-coated aspirin. The results showed a statistically significant reduction in the rates of gastric ulcers without increasing the rate of major cardiovascular events or death. (PDF)
Whellan DJ, Tricoci P, Chen E, Huang Z, Leibowitz D, Vranckx P, Marhefka GD, Held C, Nicolau JC, Storey RF, Ruzyllo W, Huber K, Sinnaeve P, Weiss AT, Dery JP, Moliterno DJ, Van de Werf F, Aylward PE, White HD, Armstrong PW, Wallentin L, Strony J, Harrington RA, Mahaffey KW. Vorapaxar in acute coronary syndrome patients undergoing coronary artery bypass graft surgery: subgroup analysis from the TRACER trial (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome). J Am Coll Cardiol. 2014 Mar 25;63(11):1048-57.
This study evaluated effects of protease-activated receptor-1 antagonist vorapaxar (Merck, Whitehouse Station, New Jersey) versus placebo among the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) study patients with non-ST-segment elevation acute coronary syndromes undergoing coronary artery bypass grafting (CABG). Vorapaxar was associated with a significant reduction in ischemic events and no significant increase in major CABG-related bleeding. These data show promise for protease-activated receptor 1 antagonism in patients undergoing CABG and warrant confirmatory evidence in randomized trials. (PDF)
Whellan DJ, Ellis SJ, Kraus WE, et al. Method for establishing authorship in a multicenter clinical trial. Ann Intern Med. 2009 Sep 15;151(6):414-20.
During the implementation of the HF-ACTION trial, study leadership devised a scoring system which assigned points to participating sites based on contributions to the trial, such as the site’s rate of enrollment, adherence to the study protocol, and investigator committee participation. This novel system was used to assign authorship to investigators and study personnel across sites in a transparent and equitable manner and resulted in a wide distribution of authors across all sites. (PDF)
Prevalent digoxin use and subsequent risk of death or hospitalization in ambulatory heart failure patients with a reduced ejection fraction—Findings from the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized controlled trial
Aerobic exercise training and general health status in ambulatory heart failure patients with a reduced ejection fraction—Findings from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)trial