Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.
NCT ID: NCT03648736
Last Updated: 2020-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2018-10-10
2021-05-31
Brief Summary
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Detailed Description
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The postoperative treatment is performed according to the Standard Operating Procedures (SOPs) of the Medical clinic I -regular blood sampling is performed to monitor the patient's cardiac, renal and hepatic lab values. The patient is released on the 3-5th post-operative day.
As part of a routine outpatient visit to the Medical Clinic I 1 week and 1 month after the TASH procedure, an anamnestic record as well as a blood analysis is made. One month after the TASH procedure, an echocardiographic follow-up of the HOCM is routinely performed.
Adverse events or serious adverse events are documented, assessed and reported in accordance with GCP (good clinical practice).
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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HOCM patients
selected for routine TASH procedure
blood withdrawal
* peripheral-venous before TASH, day 1, 2, 3, one week and one month after TASH procedure
* central-venous during TASH
Interventions
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blood withdrawal
* peripheral-venous before TASH, day 1, 2, 3, one week and one month after TASH procedure
* central-venous during TASH
Eligibility Criteria
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Inclusion Criteria
* an access to blood vessels
* a person qualified for legal acts, mentally abte to follow the instructions of study stuff
Exclusion Criteria
* patients with acute infectious diseases (e.g. pneumonia)
* patients with acute myocardial ischaemia (e.g. angina pectoris or ECG alterations under strain)
* patients with acute coronary syndrome in the last three months
* patients that were hospitalized for Acute Heart Failure during the last month and had to be treated by diuretics or inotropes
* a pregnant and/or breastfeeding women
* Persons that are located by a court or administrative decision in an Institution
* Persons with a relationship of dependency to investigator
* Persons with simultaneous participation in another clinical trial
* administration of an investigational drug 30 days before start of the study
18 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Robert Stöhr, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
RWTH Aachen University, Aachen University Hospital, Medical Clinic I
Locations
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Aachen University Hospital; Medical Clinic I - Cardiology, Pneumology, Angiology and Internal Intensive Medicine
Aachen, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Jessup M, Brozena S. Heart failure. N Engl J Med. 2003 May 15;348(20):2007-18. doi: 10.1056/NEJMra021498. No abstract available.
Jessup M, Brozena SC. Epilogue: support devices for end stage heart failure. Cardiol Clin. 2003 Feb;21(1):135-9. doi: 10.1016/s0733-8651(02)00139-x.
Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011 Jan;8(1):30-41. doi: 10.1038/nrcardio.2010.165. Epub 2010 Nov 9.
Kenchaiah S, Narula J, Vasan RS. Risk factors for heart failure. Med Clin North Am. 2004 Sep;88(5):1145-72. doi: 10.1016/j.mcna.2004.04.016.
Faul C, Amaral AP, Oskouei B, Hu MC, Sloan A, Isakova T, Gutierrez OM, Aguillon-Prada R, Lincoln J, Hare JM, Mundel P, Morales A, Scialla J, Fischer M, Soliman EZ, Chen J, Go AS, Rosas SE, Nessel L, Townsend RR, Feldman HI, St John Sutton M, Ojo A, Gadegbeku C, Di Marco GS, Reuter S, Kentrup D, Tiemann K, Brand M, Hill JA, Moe OW, Kuro-O M, Kusek JW, Keane MG, Wolf M. FGF23 induces left ventricular hypertrophy. J Clin Invest. 2011 Nov;121(11):4393-408. doi: 10.1172/JCI46122. Epub 2011 Oct 10.
Leifheit-Nestler M, Grosse Siemer R, Flasbart K, Richter B, Kirchhoff F, Ziegler WH, Klintschar M, Becker JU, Erbersdobler A, Aufricht C, Seeman T, Fischer DC, Faul C, Haffner D. Induction of cardiac FGF23/FGFR4 expression is associated with left ventricular hypertrophy in patients with chronic kidney disease. Nephrol Dial Transplant. 2016 Jul;31(7):1088-99. doi: 10.1093/ndt/gfv421. Epub 2015 Dec 17.
Mirza MA, Larsson A, Melhus H, Lind L, Larsson TE. Serum intact FGF23 associate with left ventricular mass, hypertrophy and geometry in an elderly population. Atherosclerosis. 2009 Dec;207(2):546-51. doi: 10.1016/j.atherosclerosis.2009.05.013. Epub 2009 May 21.
Andrukhova O, Slavic S, Odorfer KI, Erben RG. Experimental Myocardial Infarction Upregulates Circulating Fibroblast Growth Factor-23. J Bone Miner Res. 2015 Oct;30(10):1831-9. doi: 10.1002/jbmr.2527. Epub 2015 May 6.
Andersen IA, Huntley BK, Sandberg SS, Heublein DM, Burnett JC Jr. Elevation of circulating but not myocardial FGF23 in human acute decompensated heart failure. Nephrol Dial Transplant. 2016 May;31(5):767-72. doi: 10.1093/ndt/gfv398. Epub 2015 Dec 13.
Other Identifiers
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17-164
Identifier Type: -
Identifier Source: org_study_id
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