PCI and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes (COMBI-RDN)
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|ClinicalTrials.gov Identifier: NCT02272920|
Recruitment Status : Unknown
Verified October 2014 by Elmir Omerovic, Sahlgrenska University Hospital, Sweden.
Recruitment status was: Not yet recruiting
First Posted : October 23, 2014
Last Update Posted : October 24, 2014
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 i.e. 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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Acute Myocardial Infarction||Procedure: Renal denervation||Phase 2|
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 e.g. 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?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Combined Treatment With Percutaneous Coronary Intervention and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes.|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||March 2016|
Experimental: Renal denervation
One procedure will be performed using one of the CE-marked devices for renal denervation: Medtronic Symplicity Flex, Medtronic Symplicity Spyral or St Jude EnligHTN.
Renal denervation is performed within seven days after PCI in patients with acute myocardial infarction and hypertension.
Procedure: Renal denervation
Medtronic Symplicity Flex, Medtronic Symplicity Spyral, or St Jude EnligHTN.
No Intervention: Control: Standard of care
Standard-of-care follow-up after ACS. Including nurse and physician out-patient visits.
- Left ventricular remodelling [ Time Frame: At 4 months. ]Change in left ventricular mass and volumes, as measured by magnetic resonance. Comparing intervention and control group.
- Office and 24-h ambulatory blood pressure [ Time Frame: At 4 months after renal denervation. ]Change in blood pressure. Comparing intervention and control group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272920
|Contact: Bert Andersson, Prof, MDfirstname.lastname@example.org|
|Contact: Elmir Omerovic, MD PhDemail@example.com|
|Sahlgrenska University Hospital|
|Gothenburg, Sweden, 41345|
|Contact: Bert Andersson, Professor +46 31 3427537 firstname.lastname@example.org|
|Principal Investigator:||Bert Andersson, Prof MD||Dept of Cardiology, Sahlgrenska University Hospital|