NCT01899027

Brief Summary

The primary objective of this study is to test the hypothesis that twice overnight high-dose rosuvastatin loading before RNA followed by 3-month treatment with regular doses of rosuvastatin can reduce both the acute and late renal artery damage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 15, 2013

Status Verified

July 1, 2013

Enrollment Period

2.9 years

First QC Date

July 10, 2013

Last Update Submit

July 12, 2013

Conditions

Arterial Hypertension

Keywords

Arterial hypertensionRadiofrequency ablationRenal function

Outcome Measures

Primary Outcomes (1)

  • Optical coherence tomography evidence of vascular injury induced by radiofrequency

    Evidence at optical coherence tomography of at least one of the following abnormalities: * Presence (vs. absence) of local and diffuse vasospasm (i.e. as defined by immediate loss of lumen area or lumen diameter in any part of renal artery) * Presence (vs.r absence) of oedema formation * Presence (vs. absence) of endothelial injury

    Up to 3 months

Secondary Outcomes (1)

  • Post-procedural changes in renal function

    Up to 48 hours

Study Arms (2)

Rosuvastatin Group

ACTIVE COMPARATOR

Patients will be randomized to receive two overnight high doses of Rosuvastatin (40 mg 12 h before RNA and another 10 mg dose 2 h before the procedure

Drug: Rosuvastatin

Placebo group

PLACEBO COMPARATOR

Patients will be randomized to receive two overnight high doses of Placebo before RNA and another placebo dose 2 h before the procedure

Drug: Placebo

Interventions

RosuvastatinDRUG

Patients will receive two overnight high doses of Rosuvastatin (40 mg 12 h before RNA and another 10 mg dose 2 h before the procedure

Also known as: Crestor® (rosuvastatin calcium)
Rosuvastatin Group
PlaceboDRUG

Patients will receive two overnight doses of Placebo 12 h before RNA and another dose 2 h before the procedure

Placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary and idiopathic cause of resistant arterial hypertension defined as persistent systolic blood pressure persistent systolic blood pressure - 160 mm Hg, with at least established three antihypertensive medication (including diuretics)
  • Patients with allergies to antihypertensive drugs
  • Able to understand and willing to sign the informed CF

You may not qualify if:

  • Glomerular filtration rate \<45 mL/min
  • LDL Cholesterol \>130 mg/dl
  • Presence of coronary artery disease
  • History of myopathy or elevated creatine kinase levels
  • History of Impaired liver function and/or elevated ALT and/or AST levels
  • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Sapienza

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Hypertension

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Cesare Greco, MD

    University Sapienza

    STUDY DIRECTOR

Central Study Contacts

Cesare Greco, MD

CONTACT

+390649971cesare.greco@uniroma1.it

Francesco Pelliccia, MD

CONTACT

+390649971f.pelliccia@mclink.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 15, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

July 15, 2013

Record last verified: 2013-07

Locations

IT(1)