Clinical Outcome of Patients With Resistant Hypertension Undergoing Renal Denervation

NCT04722159 | Unknown FDA Device

• 1 other identifier: ERP-2018-11640
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Studies on the impact of RDN on cardiovascular surrogate markers have shown a variety of beneficial effects: RDN is associated with a decrease blood pressure (BP), left ventricular mass (LVM), a reduction in aortic pulse-wave velocity and BP variability as well as an increase in heart rate-recovery. Several of these aspects have been observed independently of office BP response, and might be mediated by a direct modulation of the sympathetic nervous system. Moreover, several independent real - world registries have shown an association of renal denervation and sustained blood pressure reductions of clinically relevant magnitude up to 36 months of follow - up. Whether the sum of these effects may translate into an improvement of clinical outcomes remains unclear and constitutes the primary subject of proposed registry based study.

Conditions

Hypertension, Renal

Outcome Measures

Primary Outcomes (1)

• Incidence of the composite end-point of myocardial infarction, stroke, heart failure and death

  Incidence of the composite end-point of myocardial infarction, stroke, heart failure and death

  From inclusion into the registry and 6 years forward

Study Arms (2)

Treatment resistent hypertensives, treated with renal denervation

Patients having undergone renal denervation and fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP \>140/90 despite treatment with at least three antihypertensive drugs) with a follow up period of at least 5 years.

Device: Renal denervation

Treatment resistent hypertensives, conservatively treated

Patients fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP \>140/90 despite treatment with at least three antihypertensive drugs) with a follow up period of at least 5 years.

Interventions

Renal denervation DEVICE

Catheter-based inhibition of renal sympathetic nerve traffic.

Treatment resistent hypertensives, treated with renal denervation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with resistant hypertension, registered in either the The Swedish Registry for Renal Denervation or the Swedish Primary Care Cardiovascular Database (SPCCD).

You may qualify if:

• Patients registered in the Swedish Registry for Renal Denervation or SPCCD, fulfilling the criteria for resistant hypertension according to the criteria as applied in the Swedish Registry for Renal Denervation (Office BP \>140/90 despite treatment with at least three antihypertensive drugs).

You may not qualify if:

• Any patient who has withdrawn consent from being in either registry.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Hypertension, Renal

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bert Andersson

  Sahlgrenska University Hospital

  STUDY CHAIR

Central Study Contacts

Sebastian Völz, PhD

CONTACT

0046 31 3421000; sebastian.volz@vgregion.se

Bert Andersson, Professor

CONTACT

0046 31 3421000; bert.andersson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

SE (1)