Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02272920
Status:
UNKNOWN
Last Update Posted:
2014-10-24
First Post:
2014-09-11
Brief Title:
PCI and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes
Sponsor:
Sahlgrenska University Hospital Sweden
Organization:
Sahlgrenska University Hospital Sweden
Study Overview
Official Title:
Combined Treatment With Percutaneous Coronary Intervention and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes
Status:
UNKNOWN
Status Verified Date:
2014-10
Last Known Status:
NOT_YET_RECRUITING
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:
COMBI-RDN
Brief Summary:
Research hypothesis
Is the treatment with renal denervation RDN early post ACS safe and effective and does it leads to improved cardiac function and attenuation of pathologic left ventricular remodelling In a following study the hypothesis will be tested in a larger ACS population with major adverse cardiovascular events MACE after ACS as the endpoint
Rationale for conducting this study
ACS ie ST-elevation myocardial infarction STEMI and non- ST-elevation myocardial infarction non-STEMI are the most important causes of morbidity and mortality in western societies Hypertension is a major risk factor for development of ACS and heart failure but it also worsens the prognosis in patients after ACS Our research highlights the combination therapy of PCI and RDN in an ACS patient population with simultaneous hypertension
Primary objective
The primary objective of this study is to establish safety and efficacy of combined treatment with PCI and renal denervation RDN in hypertensive patients with acute coronary syndromes STEMI and non-STEMI having ventricular mass after 4 months as the primary variable
Endpoints
The primary end point is change in left ventricular mass LVM at 4 months evaluated by magnetic resonance imaging MRI
Secondary endpoints blood pressure office and 24-h ABPM and left ventricular volumes and ejection fraction
Is the treatment with renal denervation RDN early post ACS safe and effective and does it leads to improved cardiac function and attenuation of pathologic left ventricular remodelling In a following study the hypothesis will be tested in a larger ACS population with major adverse cardiovascular events MACE after ACS as the endpoint
Rationale for conducting this study
ACS ie ST-elevation myocardial infarction STEMI and non- ST-elevation myocardial infarction non-STEMI are the most important causes of morbidity and mortality in western societies Hypertension is a major risk factor for development of ACS and heart failure but it also worsens the prognosis in patients after ACS Our research highlights the combination therapy of PCI and RDN in an ACS patient population with simultaneous hypertension
Primary objective
The primary objective of this study is to establish safety and efficacy of combined treatment with PCI and renal denervation RDN in hypertensive patients with acute coronary syndromes STEMI and non-STEMI having ventricular mass after 4 months as the primary variable
Endpoints
The primary end point is change in left ventricular mass LVM at 4 months evaluated by magnetic resonance imaging MRI
Secondary endpoints blood pressure office and 24-h ABPM and left ventricular volumes and ejection fraction
Detailed Description:
The sympathetic nervous system plays a crucial role in the development and progression of hypertension and its adverse consequences Despite the availability of numerous effective pharmacologic treatments adequate blood pressure control is not achieved in a large number of subjects Patients with essential hypertension generally have increased efferent sympathetic drive to the kidneys and an increased rate of sympathetic-nerve firing possibly modulated by afferent signalling from renal sensory nerves Recently developed endovascular catheter technology enables selective denervation of the human kidney A safety and feasibility trial of this procedure identified substantial reductions of blood pressure without substantial procedure-related complications The therapeutic value seems to be present not only in hypertension but may also be of interest in many clinical conditions eg heart failure chronic end-stage renal disease and insulin resistance and diabetes
The present study COMBI-RDN is a randomised clinical trial in 40 patients to investigate safety and efficacy of the combination of Percutan Coronar Interventiom PCI and renal denervation RDN where RDN is performed early after acute coronary syndrome ACS This study is considered a pilot study to evaluate efficacy and safety in patients with ACS In a second phase there will be a randomised multicenter study in approximately 2500 patients to demonstrate whether RDN early post ACS could decrease major adverse cardiovascular events in hypertensive patients with ACS
Research hypothesis Is the treatment with renal denervation RDN early post ACS safe and effective and does it leads to improved cardiac function and attenuation of pathologic left ventricular remodelling
The present study COMBI-RDN is a randomised clinical trial in 40 patients to investigate safety and efficacy of the combination of Percutan Coronar Interventiom PCI and renal denervation RDN where RDN is performed early after acute coronary syndrome ACS This study is considered a pilot study to evaluate efficacy and safety in patients with ACS In a second phase there will be a randomised multicenter study in approximately 2500 patients to demonstrate whether RDN early post ACS could decrease major adverse cardiovascular events in hypertensive patients with ACS
Research hypothesis Is the treatment with renal denervation RDN early post ACS safe and effective and does it leads to improved cardiac function and attenuation of pathologic left ventricular remodelling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None