Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.

• Conditions: Cardiac Insufficiency
• Interventions: Other: blood withdrawal

• Registration Number: NCT03648736
• Lead Sponsor: RWTH Aachen University

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).

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-27
• Study Start: 2018-10-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HOCM patients	blood withdrawal	selected for routine TASH procedure

Primary Outcome Measures

Name	Time	Method
Time course of FGF23 (c-terminal)	1 month	from baseline to 4 weeks after TASH procedure
Time course of FGF23 (intact)	1 month	from baseline to 4 weeks after TASH procedure

Trial Locations

Locations (1)

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