Cardiac Insufficiency
Conditions
Keywords
FGF23, TASH
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).
Interventions
OTHERblood withdrawal
* peripheral-venous before TASH, day 1, 2, 3, one week and one month after TASH procedure * central-venous during TASH
Sponsors
RWTH Aachen University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
Primary ContactRobert Stöhr, Dr.
Outcome results
None listed