PCI and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes (COMBI-RDN)
Combined Treatment With Percutaneous Coronary Intervention and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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?
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Gothenburg, Zweden, 41345
- Sahlgrenska University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female and/or male aged 18-80 years
- Patients with ACS, i.e. STEMI, non-STEMI, treated with PCI
- Medical history of treated (ongoing) hypertension, or hypertension discovered at the time of ACS, and office SBP >140 despite treatment with three antihypertensive drugs.
- Ejection fraction >40%.
Exclusion Criteria:
- Increased risk of pathological bleedings
- Office systolic blood pressure <120
- Renal artery abnormalities.
- eGFR <30 mL/min
- ICD or pacemaker, or any other metallic implant not compatible with MRI
- Estimated survival time <1 year
- Not oriented to person, place and time
- Inability to understand given information about the study
- Fertile female
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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. |
Medtronic Symplicity Flex, Medtronic Symplicity Spyral, or St Jude EnligHTN.
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Geen tussenkomst: Control: Standard of care
Standard-of-care follow-up after ACS.
Including nurse and physician out-patient visits.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Left ventricular remodelling
Tijdsspanne: At 4 months.
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Change in left ventricular mass and volumes, as measured by magnetic resonance.
Comparing intervention and control group.
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At 4 months.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Office and 24-h ambulatory blood pressure
Tijdsspanne: At 4 months after renal denervation.
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Change in blood pressure.
Comparing intervention and control group.
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At 4 months after renal denervation.
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Bert Andersson, Prof MD, Dept of Cardiology, Sahlgrenska University Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 538-13
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