Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle

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Support The TransCatheter Valve and Vessels Trial TAVR Without Predilatation Safety and Efficacy Study of MicroPort’s Transcatheter Aortic Valve and Delivery System for TAVI Enable® Aortic Sutureless Bioprosthesis Evaluation Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum) HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan PREVAIL-20J – Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial RESPOND EDGE Post Market Study Impact of SAVR and TAVR on Patient’s Activity and Mobility BIOVALVE – I / II Clincial Investigation Comparison of Blood and Crystalloid Cardioplegia Ventriculo-arterial 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Insertable Cardiac Monitoring Device Reactive Oxygen Species Following Aortic Valve Replacement Biological Factors Associated With Subclinical Valvular Thrombosis Hemodynamic Comparison of Tissue Aortic Valves Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Phono- and Electrocardiogram Assisted Detection of Valvular Disease The Medtronic TAVR 2.0 US Clinical Study PREVAIL-J – Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan) Regression of Myocardial Fibrosis After Aortic Valve Replacement Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis THE ALIGN-AS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis Valvuloplasty Scoring Balloon Catheter First-in-Man Study Effect of Angiotensin II Receptor Blockers (ARB) on Left Ventricular Reverse Remodelling After Aortic Valve Replacement in Severe Valvular Aortic Stenosis Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome – (German Pilot) Quality of Care in AS IMPULSE Study Biomarkers in Aortic Stenosis – B.A.S.S. CoreValve® System Australia/New Zealand Clinical Study The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2) Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis Prospective Balloon Aortic Valvuloplasty Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis) Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis Early Surgery for Patients With Asymptomatic Aortic Stenosis Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity Bicuspid Aortic Valve Stenosis and the 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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease Statin Therapy in Asymptomatic Aortic Stenosis Validation of the “TASQ” in Patients Undergoing SAVR or TF-TAVI Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis Improving Echo Measurements in the Diagnosis of Aortic Stenosis accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis – REBOOT-PARADOX Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction Microvascular Dysfunction in Aortic Stenosis Percutaneous Aortic 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Brief Title

Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle

Official Title

Clinical Significance of Collagen Metabolism Changes in Patients With Failing and Pressure Overloaded Left Cardiac Ventricle.

Brief Summary

      As there are no clinical data in cardiology about the relationship between metabolism
      collagen changes and their clinical significance, the investigators will check the hypothesis
      that collagen metabolism changes, detected by biochemical markers for collagen metabolism,
      could predict the left ventricle remodelling and prognosis in patient with clinically
      significant pressure overloaded left ventricle.

Detailed Description

      Clinical assessment and endpoints:

      1ST day (the day of entering the hospital or the day of the first contact): Informed consent
      (see below), clinical examination, ECG, complete echocardiography evaluating the function of
      the left ventricle (EF) and the presence and the significance of valvular disease, basic
      laboratory tests incl. CKMB, troponin I, taking of blood samples (5 ml) for the detection of
      collagen metabolism markers serum level, X-ray of chest, 2nd-3rd day: clinical examination,
      ECG, basic laboratory tests incl.CKMB, troponin I (only group I) 4th day: clinical check up,
      ECG, echocardiography, taking of blood samples (5ml) for the detection of collagen metabolism
      markers serum level (only group I) 30th day: clinical examination l, ECG, echocardiography,
      taking of blood samples (5ml) for the detection of collagen metabolism markers serum level,
      24 hrs ECG monitoring (holter) 6 months: clinical examination, ECG, echocardiography, taking
      of blood samples (5ml) for the detection of collagen metabolism markers serum level, holter
      monitoring

      1 year: history, clinical examination

      Primary endpoint: combined clinical endpoint: death/repeated hospitalisation due to heart
      failure/myocardial infarction within 30 days and during 1 year follow up.

      Secondary endpoints: rehospitalisation for cardiovascular reason, clinically significant
      arrhythmias, correlations between left ventricle parameters evaluated by echocardiography and
      collagen metabolism changes evaluated by serum markers

Study Type

Observational

Primary Outcome

Primary outcome: combined clinical endpoint: death/repeated hospitalisation due to heart failure/myocardial infarction within 30 days and during 1 year follow up.

Condition

Aortic Stenosis

Study Arms / Comparison Groups

 I, observation
Description:  patients with aortic stenosis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

50

Start Date

January 2006

Completion Date

January 2009

Primary Completion Date

December 2008

Eligibility Criteria

        Inclusion Criteria:

          1. isolated severe aortic stenosis (index aortic valve area less than 0,5 cm2/m2 or mean
             transaortic pressure gradient more than 40 mm Hg, assessed by echocardiography) and
             left ventricular hypertrophy (see above)

          2. signed informed consent

        Exclusion Criteria:

          1. presence of more than mild aortic regurgitation or other significant valvular lesion

          2. impossibility to obtain echocardiographic tracing of good quality

          3. all other diseases, which significantly influence collagen metabolism (renal failure,
             insulin dependent diabetes mellitus, bone diseases, hepatic failure)

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jirmář Radovan, M.D., Ph.D., ,

Location Countries

Czech Republic

Location Countries

Czech Republic

Administrative Informations

NCT ID

NCT00693797

Organization ID

NR/9022-3

Study Sponsor

Charles University, Czech Republic

Collaborators

 Ministry of Health, Czech Republic

Study Sponsor

Jirmář Radovan, M.D., Ph.D., Principal Investigator, Faculty hospital Královské Vinohrady

Verification Date

April 2009