Evaluation of Safety Mechanisms of Renal Radioablation(RSRA)for Uncontrolled Hypertension

NCT01966952 | Terminated DMC

• 1 other identifier: 20130444-01H
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Renal sympathetic radioablation disrupts the nerves by high radiofrequency signal which creates localized heat, eliminates the signal and decrease blood pressure. The main purpose of this study is to evaluate blood pressure 12 months after radioablation, and to evaluate the short and long-term effects of the renal radioablation on the extent of changes in urine catecholamines level, vascular stiffness, and sympathetic nerve activity as linked with the changes in blood pressure. The study will also evaluate the effect radioablation has on the renal arteries as well as develop teaching sessions for family physicians and other specialists to educate them on this new treatment.

Conditions

Uncontrolled Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood pressure change post RSRA treatment

  Blood pressure(BP)will be assessed post Renal Radiosympathetic radioablation RSRA)by 24-hr Ambulatory blood pressure monitor (ABPM) using the daytime average of systolic BP

  12 months

Secondary Outcomes (2)

• efficacy

  1-3-6-&12 months

• Safety

  12 months

Other Outcomes (1)

• Education

  24months

Study Arms (1)

Resistant Hypertension

Resistant hypertension as described as; patients with uncontrolled hypertension on 3 or more antihypertensive medications with no secondary causes for hypertension (i.e. hyperaldosteronism, renal artery stenosis)

Eligibility Criteria

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

Study Population

All patients will be recruited from the Hypetension Units at The Ottawa Hospital and the University of Ottawa Heart Institute. Only patients with uncontrolled hypertension will be eligable.

You may qualify if:

• Adult patients (\>18 years)
• resistant HTN defined as daytime BP readings above 140/90 mmHg (as assessed from 24-hr ABPM))
• on 4 or more BP lowering drugs

You may not qualify if:

• pregnant patients
• Secondary forms of hypertension
• patients with following conditions: eGFR \<45 ml/min/1.75 m2,
• active infection,
• known coagulopathies,
• acute coronary syndrome and/or within 6 months post acute coronary event,
• clinically significant arrhythmias,
• within 6 months post stroke/TIA, severe liver disease;
• psychiatric disorders and/or otherwise unable to sign consent.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

The Hypetension Unit of The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marcel Ruzicka, MD

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 22, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

CA (1)