NCT03628443|Unknown
Cardiorenal Risk Stratification Pilot Study
CRiSPS
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CRiSPS
Sponsor study identifier
observational
100
1 country
1
Study Start
July 19, 2018
Actual (reported)Primary Completion
October 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is prospective cohort study with the purpose of improving our understanding of morbidity and mortality risk in patients with heart failure and chronic kidney disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 19, 2018
Actual (reported)August 9, 2018
Actual (reported)August 14, 2018
Actual (reported)October 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mortality
The occurrence of death
1 year from sample date
Worsening Renal Function
Significant, persistently decreased in estimated glomerular filtration rate
1 year from sample date
Worsening Cardiac Function
Decreased ejection fraction, newly documented structural abnormality
1 year from sample date
This group has patients managed with all types of heart failure without concomitant chronic kidney disease.
This group has patients managed with all types of heart failure with concomitant chronic kidney disease, without evidence of sustained hyperphosphatemia.
A sample of blood is tested for levels of fibroblast growth factor 23
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Control Arm: People seen in the outpatient setting with congestive heart failure without renal impairment. Study Arm: People seen in the outpatient setting with congestive heart failure that have some form of renal impairment that did not start the study while on hemodialysis.
Coney Island Hospital
Brooklyn, New York, 11235, United States
Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.
Smith GL, Lichtman JH, Bracken MB, Shlipak MG, Phillips CO, DiCapua P, Krumholz HM. Renal impairment and outcomes in heart failure: systematic review and meta-analysis. J Am Coll Cardiol. 2006 May 16;47(10):1987-96. doi: 10.1016/j.jacc.2005.11.084. Epub 2006 Apr 24.
Blood in EDTA
George Juang, MD
Coney Island Hospital
First Submitted
August 9, 2018
First Posted
August 14, 2018
Study Start
July 19, 2018
Actual (reported)Primary Completion
October 31, 2019
Estimated (date passed)DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure
End-Stage Renal Disease Progression
Progression of patient's health condition requiring the initiation of hemodialysis
1 year from sample date
Hospitalizations
1 year from sample date
Increased Medication Use
1 year from sample date
Worsening Control of Co-Morbidities
1 year from sample date
Urgent visits
1 year from sample date
Myocardial Infarction
1 year from sample date
Contact the study team to confirm eligibility.
Prie D, Friedlander G. Genetic disorders of renal phosphate transport. N Engl J Med. 2010 Jun 24;362(25):2399-409. doi: 10.1056/NEJMra0904186. No abstract available.
Prie D, Urena Torres P, Friedlander G. Latest findings in phosphate homeostasis. Kidney Int. 2009 May;75(9):882-9. doi: 10.1038/ki.2008.643. Epub 2009 Feb 4.
Ferrari SL, Bonjour JP, Rizzoli R. Fibroblast growth factor-23 relationship to dietary phosphate and renal phosphate handling in healthy young men. J Clin Endocrinol Metab. 2005 Mar;90(3):1519-24. doi: 10.1210/jc.2004-1039. Epub 2004 Dec 21.
Bogadel'nikov IV. [State of the kallikrein-kinin system in bacterial poisoning]. Zh Mikrobiol Epidemiol Immunobiol. 1978 Nov;(11):20-5. No abstract available. Russian.
Gutierrez OM, Mannstadt M, Isakova T, Rauh-Hain JA, Tamez H, Shah A, Smith K, Lee H, Thadhani R, Juppner H, Wolf M. Fibroblast growth factor 23 and mortality among patients undergoing hemodialysis. N Engl J Med. 2008 Aug 7;359(6):584-92. doi: 10.1056/NEJMoa0706130.
Fliser D, Kollerits B, Neyer U, Ankerst DP, Lhotta K, Lingenhel A, Ritz E, Kronenberg F; MMKD Study Group; Kuen E, Konig P, Kraatz G, Mann JF, Muller GA, Kohler H, Riegler P. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. J Am Soc Nephrol. 2007 Sep;18(9):2600-8. doi: 10.1681/ASN.2006080936. Epub 2007 Jul 26.
Ikee R, Tsunoda M, Sasaki N, Sato N, Hashimoto N. Emerging effects of sevelamer in chronic kidney disease. Kidney Blood Press Res. 2013;37(1):24-32. doi: 10.1159/000343397. Epub 2013 Mar 6.
Liu S, Quarles LD. How fibroblast growth factor 23 works. J Am Soc Nephrol. 2007 Jun;18(6):1637-47. doi: 10.1681/ASN.2007010068. Epub 2007 May 9.
Larsson T, Nisbeth U, Ljunggren O, Juppner H, Jonsson KB. Circulating concentration of FGF-23 increases as renal function declines in patients with chronic kidney disease, but does not change in response to variation in phosphate intake in healthy volunteers. Kidney Int. 2003 Dec;64(6):2272-9. doi: 10.1046/j.1523-1755.2003.00328.x.
Seiler S, Cremers B, Rebling NM, Hornof F, Jeken J, Kersting S, Steimle C, Ege P, Fehrenz M, Rogacev KS, Scheller B, Bohm M, Fliser D, Heine GH. The phosphatonin fibroblast growth factor 23 links calcium-phosphate metabolism with left-ventricular dysfunction and atrial fibrillation. Eur Heart J. 2011 Nov;32(21):2688-96. doi: 10.1093/eurheartj/ehr215. Epub 2011 Jul 6.
Tanaka S, Fujita S, Kizawa S, Morita H, Ishizaka N. Association between FGF23, alpha-Klotho, and Cardiac Abnormalities among Patients with Various Chronic Kidney Disease Stages. PLoS One. 2016 Jul 11;11(7):e0156860. doi: 10.1371/journal.pone.0156860. eCollection 2016.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 16, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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