Clinical trial NCT03648736: Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.
Official title: Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Insufficiency
Keywords: FGF23, TASH
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HOCM patients selected for routine TASH procedure

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Time course of FGF23 (c-terminal)
timeFrame: 1 month
measure: Time course of FGF23 (intact)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Aachen University Hospital; Medical Clinic I - Cardiology, Pneumology, Angiology and Internal Intensive Medicine
state: NRW
Study officials:
affiliation: RWTH Aachen University, Aachen University Hospital, Medical Clinic I
name: Robert Stöhr, Dr. med.
role: PRINCIPAL_INVESTIGATOR
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