Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06140914
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-11-14
Brief Title:
Biological Mechanisms Behind Resynchronization Therapy in Heart Failure
Sponsor:
Region Stockholm
Organization:
Region Stockholm
Study Overview
Official Title:
Biological Mechanisms Behind Resynchronization Therapy in Heart Failure
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Heart failure is a common disease affecting 2-3 of the population in the western world About 30 of patients with heart failure and reduced ejection fraction display signs of electrical dyssynchrony on ECG usually left bundle branch block LBBB which is associated with a worse prognosis Cardiac resynchronization therapy CRT reduce mortality for patients with dyssynchronic heart failure defined as ejection fraction EF or 35 and LBBB About 13 of the patients that fit CRT criteria will not respond to CRT Which patients that will turn out to be non-responders cannot be anticipated beforehand
We have started a clinical study to collect blood samples heart tissue and clinical data from heart failure patients eligible for CRT and a control group of heart failure patients on medical therapy Patients will be assessed before CRT implantation or early after initiation of medical treatment at 3 months 6 months and 12 months
Blood samples and tissue will be analysed in the search for i biomarkers to separate CRT responders from non-responders and ii mechanisms behind the remodelling observed in CRT and with medical therapy
We have started a clinical study to collect blood samples heart tissue and clinical data from heart failure patients eligible for CRT and a control group of heart failure patients on medical therapy Patients will be assessed before CRT implantation or early after initiation of medical treatment at 3 months 6 months and 12 months
Blood samples and tissue will be analysed in the search for i biomarkers to separate CRT responders from non-responders and ii mechanisms behind the remodelling observed in CRT and with medical therapy
Detailed Description:
In dyssynchrony the conduction of electrical signals within the heart is prolonged causing a delay between the activation and contraction of septum and lateral left ventricular wall In turn this results in uncoordinated and ineffective heart work Dyssynchrony is accompanied by cardiac remodeling with dilatation of the left chamber Whether dilatation is an effect or a cause of dyssynchrony is unclear and likely different for different patients Cardiac resynchronization therapy CRT is a pacemaker with an extra electrode that will stimulate the right and left ventricle simultaneously resulting in resynchronization
We have started a clinical study to collect blood samples heart tissue and clinical data echocardiography ECG medical records from heart failure patients eligible for CRT and a control group of heart failure patients on medical therapy Patients will be assessed before CRT implantation or early after initiation of medical treatment at 3 months 6 months and 12 months A subset of the patients in the CRT group will also also be subjected to a heart biopsy before CRT implantation and at 3 months At each time point all patients will be assessed with echocardiography ECG and blood sampling The blood samples will be analyzed regarding proteins and exosomal miRNA The heart tissue will be frozen and analyzed regarding proteins RNA and contractility
Endothelial function is also known to play a crucial role in heart failure and will be evaluated at inclusion 3 and 12 months using EndoPAT Red blood cells RBCs are collected to determine whether they may affect endothelial cell function
We have started a clinical study to collect blood samples heart tissue and clinical data echocardiography ECG medical records from heart failure patients eligible for CRT and a control group of heart failure patients on medical therapy Patients will be assessed before CRT implantation or early after initiation of medical treatment at 3 months 6 months and 12 months A subset of the patients in the CRT group will also also be subjected to a heart biopsy before CRT implantation and at 3 months At each time point all patients will be assessed with echocardiography ECG and blood sampling The blood samples will be analyzed regarding proteins and exosomal miRNA The heart tissue will be frozen and analyzed regarding proteins RNA and contractility
Endothelial function is also known to play a crucial role in heart failure and will be evaluated at inclusion 3 and 12 months using EndoPAT Red blood cells RBCs are collected to determine whether they may affect endothelial cell function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None