PCI and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes

Hypertension Clinical Trial

— COMBI-RDN  

Official title:

Combined Treatment With Percutaneous Coronary Intervention and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02272920
• Other study ID #: 538-13
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 11, 2014
• Last updated: October 23, 2014
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2014
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Bert Andersson, Prof, MD
• Phone: +46313427537
• Email: bert.andersson[@]vgregion.se
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Hypertension
• Myocardial Infarction

Intervention

Procedure:
• Renal denervation
Medtronic Symplicity Flex, Medtronic Symplicity Spyral, or St Jude EnligHTN.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular remodelling	Change in left ventricular mass and volumes, as measured by magnetic resonance. Comparing intervention and control group.	At 4 months.	No
Secondary	Office and 24-h ambulatory blood pressure	Change in blood pressure. Comparing intervention and control group.	At 4 months after renal denervation.	Yes