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Cardiac InsufficiencyTASHNCT03648736

Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.

An observational study of Cardiac Insufficiency, run by RWTH Aachen University at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Insufficiency
What is being tested?
blood withdrawal
How many people
40 participants
Where
1 siteGermany
Study dates
10 Oct 2018to May 2021
How long will I take part?
4 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HOCM patients selected for routine TASH procedure

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Robert Stöhr, Dr. contact

+49 241 80 36351

rstoehr@ukaachen.de

Germany1 site, 1 recruiting

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

    Aachen, North Rhine-Westphalia, D-52074

    Robert Stöhr, Dr. med., +49 241 80 36351, rstoehr@ukaachen.de

    Recruiting

Other trials in Germany

About this study

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.

Read the detailed 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).

Being tested
blood withdrawal
Keywords
FGF23, TASH
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood withdrawalOther

    • peripheral-venous before TASH, day 1, 2, 3, one week and one month after TASH procedure
    • central-venous during TASH
Study groups in NCT03648736
Study groupRoleWhat they receive
HOCM patientsselected for routine TASH procedure
Receives: Other: blood withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time course of FGF23 (c-terminal)

    from baseline to 4 weeks after TASH procedure

    Measured: 1 month

  2. Time course of FGF23 (intact)

    from baseline to 4 weeks after TASH procedure

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2018
  2. Study start10 Oct 2018
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
40 participants (estimated)
Target duration
4 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT03648736
Sponsor's protocol ID
17-164
Acronym
TASH
Status last verified
Mar 2020
First submitted
22 Aug 2018
Last updated
12 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The results of the study will be published in a scientific paper. The Ethics Committee will be informed about the results of the study.

Publications

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

    PubMed 12748317

  • 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.

    PubMed 12790052

  • 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.

    PubMed 21060326

  • 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.

    PubMed 15331311

  • 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.

    PubMed 21985788

  • 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.

    PubMed 26681731

  • 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.

    PubMed 19524924

  • 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.

    PubMed 25858796

  • 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.

    PubMed 26666498

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Insufficiency, run by RWTH Aachen University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Robert Stöhr, Dr. (+49 241 80 36351, rstoehr@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time course of FGF23 (c-terminal) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03648736, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.

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