Our initial focus was on conducting clinical trials with the goal of identifying underlying causes of unexplained anemia in the elderly and developing better treatments. Two clinical trials were initiated; IV Iron for patients with marginal iron stores and Salsalate for patients with evidence of inflammation. These studies experienced significant recruitment difficulties despite substantial efforts to improve recruitment, and had to be closed prematurely. However the outcome of the IV Iron trial has been published (1) and a brief report of toxicity with Salsalate has also been published (2). Data collected on the potential underlying basis of these anemias is currently being analyzed. In addition PACTTE collaborated with the investigative team of the Testosterone trials to assess the impact of Testosterone on Unexplained anemia of the elderly. A manuscript describing these findings is currently under review at JAMA.
Because of these recruitment difficulties, we have shifted our emphasis to the conduct of a large pragmatic cluster randomized trial relating broadly to anemia in the elderly. We have engineered a partnership with the Cardiovascular Research Network (CVRN) and the CVRN-HF subgroup to do so, and are currently working on a new concept, the Reversible Low Blood Counts in Older Heart Failure Patients: Evaluation and Associated Risks and Treatment (RBC HEART) Study. An initial observational analysis of patients with anemia and heart failure has been completed and is being analyzed and plans are under way for the second phase which will entail the prospective pragmatic trial of an approach to improve diagnosis and treatment of heart failure related anemia.
The Duke Clinical Research Institute (DCRI) will continue to serve as the Coordinating Center for the PACTTE consortium. The DCRI is the world’s largest academic clinical research organization, combines the clinical expertise and academic leadership of Duke University School of Medicine with the full-service operational capabilities of a major contract research organization.
The Cardiovascular Research Network (CVRN) aims to provide a unique national resource that leverages the network’s cardiovascular expertise, diverse community-based study populations, and rich electronic data systems from a consortium of currently 10 geographically diverse health plans (~10 million members) in the United States with integrated research divisions. The CVRN’s overall goals are to:
- Provide more robust cardiovascular disease and related health care surveillance data than currently available
- Promote research on clinical practice and quality of care
- Enable assessment of new diagnostic and therapeutic technologies and clinical guidelines on cardiovascular disease and risk factor incidence, prevalence, clinical management, and patient outcomes over time
- Promote research on determinants of disease for uncommon disease phenotypes
- Create opportunities for interested non-network researchers to collaborate with CVRN investigators on high-priority cardiovascular issues
Further information can be found on cvrn.org.
Dr. Harvey Cohen, Director of the Center for the Study of Aging and Human Development at Duke University will continue to serve as the Principal Investigator for the PACTTE Consortium.
Dr. Andrew Artz, at the University of Chicago, will continue to serve as the Co-Principal Investigator for the PACTTE Consortium.
Dr. Stanley Schrier, at Stanford University, will continue to serve as the Steering Committee Chairman.
Dr. Alan Go, Director of the CVRN at the Kaiser Permanente Northern California Division of Research, will serve as the Principal Investigator of the RBC HEART Study.
Please come back soon to view our updated site and learn more about PACTTE and our new and exciting approach.
Price E, Artz AS, Barnhart H, Sapp S, Chelune G, Ershler WB, Walston JD, Gordeuk VR, Berger NA, Reuben D, Prchal J, Rao SVm, Roy CN, Supiano MA, Schrier SL, Cohen HJ. A Prospective Randomized Wait List Control Trial of Intravenous Iron Sucrose in Older Adults with Unexplained Anemia and Serum Ferritin 20-200 ng/mL blood Cells, Molecules and Diseases. Blood Cells Mol Dis. 2014 Dec; 53(4):221-30. PMCID: PMC4198614
Cohen HJ, Walston JD, Rao SV, Schrier SL, Artz A, Partnership for Anemia: Clinical and Translational Trials in the Elderly Consortium. Renal Toxicity Associated with Salsalate in Elderly Patients with Anemia. J Am Geriatr Soc. 2016 Apr; 64(4):898-9. doi: 10.1111/jgs.14065. PMCID:PMC4863444