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PCI and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes (COMBI-RDN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Elmir Omerovic, Sahlgrenska University Hospital, Sweden

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 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.

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.


Condition or disease Intervention/treatment Phase
Hypertension Acute Myocardial Infarction Procedure: Renal denervation Phase 2

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 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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Office and 24-h ambulatory blood pressure [ Time Frame: At 4 months after renal denervation. ]
    Change in blood pressure. Comparing intervention and control group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female and/or male aged 18-80 years
  3. Patients with ACS, i.e. STEMI, non-STEMI, treated with PCI
  4. Medical history of treated (ongoing) hypertension, or hypertension discovered at the time of ACS, and office SBP >140 despite treatment with three antihypertensive drugs.
  5. Ejection fraction >40%.

Exclusion Criteria:

  1. Increased risk of pathological bleedings
  2. Office systolic blood pressure <120
  3. Renal artery abnormalities.
  4. eGFR <30 mL/min
  5. ICD or pacemaker, or any other metallic implant not compatible with MRI
  6. Estimated survival time <1 year
  7. Not oriented to person, place and time
  8. Inability to understand given information about the study
  9. Fertile female

Information from the National Library of Medicine

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


Contacts
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Contact: Bert Andersson, Prof, MD +46313427537 bert.andersson@vgregion.se
Contact: Elmir Omerovic, MD PhD +46313427560 elmir.omerovic@wlab.gu.se

Locations
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Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Contact: Bert Andersson, Professor    +46 31 3427537    bert.andersson@gu.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Bert Andersson, Prof MD Dept of Cardiology, Sahlgrenska University Hospital

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Responsible Party: Elmir Omerovic, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02272920    
Other Study ID Numbers: 538-13
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Infarction
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases