Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.

NCT03648736 | Unknown

• 1 other identifier: 17-164
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Insufficiency

Keywords

FGF23, TASH

Outcome Measures

Primary Outcomes (2)

• Time course of FGF23 (c-terminal)

  from baseline to 4 weeks after TASH procedure

  1 month

• Time course of FGF23 (intact)

  from baseline to 4 weeks after TASH procedure

  1 month

Study Arms (1)

HOCM patients

selected for routine TASH procedure

Other: blood withdrawal

Interventions

blood withdrawal OTHER

* peripheral-venous before TASH, day 1, 2, 3, one week and one month after TASH procedure * central-venous during TASH

HOCM patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HOCM patients selected for routine TASH procedure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Aachen University Hospital; Medical Clinic I - Cardiology, Pneumology, Angiology and Internal Intensive Medicine

Aachen, North Rhine-Westphalia, D-52074, Germany

RECRUITING

Related Publications (9)

• Jessup M, Brozena S. Heart failure. N Engl J Med. 2003 May 15;348(20):2007-18. doi: 10.1056/NEJMra021498. No abstract available.

  PMID: 12748317 BACKGROUND

• 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.

  PMID: 12790052 BACKGROUND

• 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.

  PMID: 21060326 BACKGROUND

• 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.

  PMID: 15331311 BACKGROUND

• 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.

  PMID: 21985788 RESULT

• 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.

  PMID: 26681731 RESULT

• 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.

  PMID: 19524924 RESULT

• 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.

  PMID: 25858796 RESULT

• 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.

  PMID: 26666498 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Robert Stöhr, Dr. med.

  RWTH Aachen University, Aachen University Hospital, Medical Clinic I

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Stöhr, Dr.

CONTACT

+49 241 80 36351; rstoehr@ukaachen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 27, 2018
• Study Start: October 10, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)