N/A N=17 Randomized Treatment

Renal Denervation for Management of Drug-Resistant Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01505010 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement) — 0.7; -21.7 mmHg — p=0.018

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Renal denervation (Procedure)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: KU Leuven
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement)	0.7; -21.7	0.018 sig
PRIMARY Change in Glomerular Filtration Rate	81.6; 92.4	0.86
SECONDARY The Intensity of Medical Treatment	4; 3	0.032 sig

Summary

INSPiRED is a multicenter parallel-group trial comparing usual medical treatment (control group) or usual medical treatment plus renal denervation (intervention). In both groups adherence will be monitored both before randomization and during 36 months of follow-up.

Eligibility Criteria

Inclusion criteria

Women and men are eligible. Women of reproductive age should apply effective contraception.
Age ranges from 20 years (inclusive) to less than 70 years.
Patients should have essential hypertension.
Treatment-resistant hypertension in patients taking a stable drug regimen for at least 4 weeks consisting of 3 or more antihypertensive medications from different classes, including a diuretic.
Under maximal therapy, office blood pressure should be ≥140/90 mmHg and the 24-h ambulatory blood pressure should be 130 mm Hg systolic or 80 mm Hg diastolic or higher.
eGFR must be ≥ 60 mL/min/1.73 m2.
The patients should accept to have adherence checked before randomisation and during supervised follow-up, but both patients and doctors will remain blinded to the results;
Informed written consent.

Exclusion criteria

Suboptimal clinical context, because of recent history or concurrent disease.
Isolated systolic and diastolic hypertension.
Body-mass index ≥ 40kg/m2.
The anatomy of the renal arteries is suboptimal for renal denervation.
Pregnancy.
Alcohol or substance abuse or psychiatric illnesses.
Participation in other study.
The clinical context is suboptimal for renal denervation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01505010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.