Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.

NCT ID: NCT03648736

Last Updated: 2020-03-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-10

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Cardiac Insufficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HOCM patients

selected for routine TASH procedure

blood withdrawal

Intervention Type OTHER

* 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Robert Stöhr, Dr.

Role: CONTACT

+49 241 80 36351

Facility Contacts

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Robert Stöhr, Dr. med.

Role: primary

+49 241 80 36351

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.

Reference Type BACKGROUND
PMID: 12748317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12790052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21060326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15331311 (View on PubMed)

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.

Reference Type RESULT
PMID: 21985788 (View on PubMed)

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.

Reference Type RESULT
PMID: 26681731 (View on PubMed)

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.

Reference Type RESULT
PMID: 19524924 (View on PubMed)

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.

Reference Type RESULT
PMID: 25858796 (View on PubMed)

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.

Reference Type RESULT
PMID: 26666498 (View on PubMed)

Other Identifiers

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17-164

Identifier Type: -

Identifier Source: org_study_id

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