PCI and Renal Denervation in Hypertensive Patients With Acute Coronary Syndromes

NCT02272920 | Unknown Phase 2 DMC

• 1 other identifier: 538-13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Left ventricular remodelling

  Change in left ventricular mass and volumes, as measured by magnetic resonance. Comparing intervention and control group.

  At 4 months.

Secondary Outcomes (1)

• Office and 24-h ambulatory blood pressure

  At 4 months after renal denervation.

Study Arms (2)

Renal denervation

EXPERIMENTAL

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

Control: Standard of care

NO INTERVENTION

Standard-of-care follow-up after ACS. Including nurse and physician out-patient visits.

Interventions

Renal denervation PROCEDURE

Medtronic Symplicity Flex, Medtronic Symplicity Spyral, or St Jude EnligHTN.

Renal denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bert Andersson, Prof MD

  Dept of Cardiology, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bert Andersson, Prof, MD

CONTACT

+46313427537; bert.andersson@vgregion.se

Elmir Omerovic, MD PhD

CONTACT

+46313427560; elmir.omerovic@wlab.gu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: October 23, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: October 24, 2014

Record last verified: 2014-10

Locations

SE (1)