Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.

Cardiac Insufficiency Clinical Trial

— TASH  

Official title:

Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03648736
• Other study ID #: 17-164
• Status: Recruiting
• Start date: October 10, 2018
• Est. completion date: May 2021

Study information

• Verified date: March 2020
• Source: RWTH Aachen University
• Contact: Robert Stöhr, Dr.
• Phone: +49 241 80 36351
• Email: rstoehr[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study evaluates the released myocardial substances in blood of HOCM patients after TASH procedure (small "controlled" myocardial infarction). This helps to identify new pathomechanisms and biomarker and thus provides a better understanding of development and progress of cardiac insufficiency.

Description:

All patients who receive a TASH procedure in the Medical Clinic I routinely receive routinely implementation of arterial pressure catheter for invasive blood pressure monitoring (usually Arteria radialis) as well as a central venous catheter. Directly after the procedure, the blood is taken through the central venous catheter. The operation is then terminated as planned.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a clinical indication for TASH procedure

• an access to blood vessels

• a person qualified for legal acts, mentally abte to follow the instructions of study stuff

Exclusion Criteria:

• patients with severe anaemia - Hb <8 mg/dL

• 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

Related Conditions & MeSH terms

• Cardiac Insufficiency
• Heart Failure

Intervention

Other:
• blood withdrawal
peripheral-venous before TASH, day 1, 2, 3, one week and one month after TASH procedure central-venous during TASH

Locations

Country	Name	City	State
Germany	Aachen University Hospital; Medical Clinic I - Cardiology, Pneumology, Angiology and Internal Intensive Medicine	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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. — View Citation

Andrukhova O, Slavic S, Odörfer 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. — View Citation

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. Review. — View Citation

Faul C, Amaral AP, Oskouei B, Hu MC, Sloan A, Isakova T, Gutiérrez 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, Gadegb — View Citation

Jessup M, Brozena S. Heart failure. N Engl J Med. 2003 May 15;348(20):2007-18. Review. — View Citation

Jessup M, Brozena SC. Epilogue: support devices for end stage heart failure. Cardiol Clin. 2003 Feb;21(1):135-9. Review. — View Citation

Kenchaiah S, Narula J, Vasan RS. Risk factors for heart failure. Med Clin North Am. 2004 Sep;88(5):1145-72. Review. — View Citation

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 ventricul — View Citation

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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time course of FGF23 (c-terminal)	from baseline to 4 weeks after TASH procedure	1 month
Primary	Time course of FGF23 (intact)	from baseline to 4 weeks after TASH procedure	1 month