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Denervation of the REnal Artery in Metabolic Syndrome (DREAMS)

Primary Purpose

Insulin Resistance, Blood Pressure

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Renal denervation
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Insulin resistance, Insulin sensitivity, HOMA-IR, blood pressure, Renal denervation, renal sympathetic denervation, renal ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients should have a high fasting glucose (fasting serum glucose ≥5.6 mmol/L (≥100 mg/dL)), without the use of antidiabetic drugs at the time of inclusion AND should have a 24 hour ambulatory SBP >130 mmHg, without the use of antihypertensive drugs at the time of inclusion.
  • Patients should fulfil one or more other criteria to meet the definition of the metabolic syndrome.
  • Individual understands the study procedures, alternative treatments available, risks involved with the study and voluntarily agrees to participate by giving informed consent.
  • Individual is over 18 years of age on the day of signing informed consent.

Exclusion Criteria:

  • SBP >180 mmHg and/or DBP >110 mmHg during one or more screening measurements.
  • 24-hour ambulatory SBP >170 mmHg and/or 24-hour ambulatory DBP >100 mmHg at time of inclusion.
  • Individual is treated with more than one type of antihypertensive medication at time of inclusion.
  • Individual is treated with more than one type of drug for diabetes mellitus 2 at time of inclusion and/or the medication for DM type 2 can not be stopped.
  • Individual has a treatable secondary cause of hypertension.
  • Individual has renal artery anatomy that is ineligible for treatment.
  • Individual has an estimated glomerular filtration rate (eGFR) of <45mL/min/1.73m2, using the MDRD calculation.
  • Individual has type 1 diabetes mellitus.
  • Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
  • Individual has scheduled or planned surgery or cardiovascular intervention in the next 6 months.
  • Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous.
  • Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for RF energy delivery.
  • Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, or significant anaemia).
  • Individual is pregnant, nursing or planning to be pregnant.
  • Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
  • Individual is currently enrolled in another investigational drug or device trial.

  • Individual is currently being treated with any of the following medications:

    • Drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone)
    • Acenocoumarol or phenprocoumon that cannot be temporarily stopped for the procedure.

Sites / Locations

  • UMC Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal denervation

Arm Description

Outcomes

Primary Outcome Measures

Difference in Insulin resistance before and 12 months after renal denervation
To investigate the influence of percutaneous renal sympathetic denervation on insulin resistance. Hereby evaluating an Oral Glucose Tolerance Test before and after renal denervation

Secondary Outcome Measures

Difference in blood pressure before and after renal denervation
Safety
Major adverse events, characterized by myocardial infarction, cerebrovascular accident or all-cause mortality.
Fasting glucose before and after renal denervation
Change in Muscle sympathetic nerve activity (MSNA)after renal denervation

Full Information

First Posted
October 25, 2011
Last Updated
December 28, 2014
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT01465724
Brief Title
Denervation of the REnal Artery in Metabolic Syndrome
Acronym
DREAMS
Official Title
Sympathetic Denervation of the Renal Artery for the Treatment of Obesity-related Hypertension and Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The current prevalence of hypertension as part of the metabolic syndrome is substantial and is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a common and key factor in disease states as obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity. This current study is an observational feasibility study, with the aim to investigate the effect of renal denervation on changes in insulin resistance and blood pressure in patients with obesity related hypertension. The investigators will study different variables: a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory. Hypothesis The investigators hypothesize that renal denervation has a beneficial effect on insulin resistance. The investigators hypothesize that there will be no complications related to the device or procedure.
Detailed Description
Objectives: The objectives of this study are: to compare changes in insulin resistance in patients with ORH after RDN; to evaluate the safety of PRDN in this patient group; to compare changes in blood pressure, laboratory parameters, arterial stiffness and SNS-activity after PRDN. Study design: Prospective observational feasibility-study. Study population: Patients with a high fasting glucose (fasting serum glucose ≥5.6 mmol/L(100 mg/dL)) and with an ambulatory systolic blood pressure >130mmHg. Major endpoints: The effect of RDN on: insulin resistance, blood pressure and major adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Blood Pressure
Keywords
Insulin resistance, Insulin sensitivity, HOMA-IR, blood pressure, Renal denervation, renal sympathetic denervation, renal ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal denervation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Renal denervation
Other Intervention Name(s)
Symplicity Catheter system
Intervention Description
percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system.
Primary Outcome Measure Information:
Title
Difference in Insulin resistance before and 12 months after renal denervation
Description
To investigate the influence of percutaneous renal sympathetic denervation on insulin resistance. Hereby evaluating an Oral Glucose Tolerance Test before and after renal denervation
Time Frame
T=0, T=6 months, and t=12 months
Secondary Outcome Measure Information:
Title
Difference in blood pressure before and after renal denervation
Time Frame
t=0, t=6 months, and t=12 months
Title
Safety
Description
Major adverse events, characterized by myocardial infarction, cerebrovascular accident or all-cause mortality.
Time Frame
one year
Title
Fasting glucose before and after renal denervation
Time Frame
t=0 and t=12 months
Title
Change in Muscle sympathetic nerve activity (MSNA)after renal denervation
Time Frame
t=0 and t=6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients should have a high fasting glucose (fasting serum glucose ≥5.6 mmol/L (≥100 mg/dL)), without the use of antidiabetic drugs at the time of inclusion AND should have a 24 hour ambulatory SBP >130 mmHg, without the use of antihypertensive drugs at the time of inclusion. Patients should fulfil one or more other criteria to meet the definition of the metabolic syndrome. Individual understands the study procedures, alternative treatments available, risks involved with the study and voluntarily agrees to participate by giving informed consent. Individual is over 18 years of age on the day of signing informed consent. Exclusion Criteria: SBP >180 mmHg and/or DBP >110 mmHg during one or more screening measurements. 24-hour ambulatory SBP >170 mmHg and/or 24-hour ambulatory DBP >100 mmHg at time of inclusion. Individual is treated with more than one type of antihypertensive medication at time of inclusion. Individual is treated with more than one type of drug for diabetes mellitus 2 at time of inclusion and/or the medication for DM type 2 can not be stopped. Individual has a treatable secondary cause of hypertension. Individual has renal artery anatomy that is ineligible for treatment. Individual has an estimated glomerular filtration rate (eGFR) of <45mL/min/1.73m2, using the MDRD calculation. Individual has type 1 diabetes mellitus. Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques. Individual has scheduled or planned surgery or cardiovascular intervention in the next 6 months. Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous. Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for RF energy delivery. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, or significant anaemia). Individual is pregnant, nursing or planning to be pregnant. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements. Individual is currently enrolled in another investigational drug or device trial. Individual is currently being treated with any of the following medications: Drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone) Acenocoumarol or phenprocoumon that cannot be temporarily stopped for the procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel Voskuil, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Willemien Verloop, MD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

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Denervation of the REnal Artery in Metabolic Syndrome

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