Renal Denervation for Management of Drug-Resistant Hypertension

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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Objectives:

To compare the blood pressure lowering efficacy and safety of renal denervation vs. usual medical therapy. The primary endpoints for efficacy and safety are the baseline-adjusted between-group differences in 24-h systolic blood pressure and in glomerular filtration rate as estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Secondary endpoints for efficacy and safety include other indexes of blood pressure control and renal function, metabolic variables and morbidity and mortality. These endpoints will be assessed 6 months after randomization.

Trial design:

Randomized controlled trial with blinded assessment of the primary and secondary endpoints. The study consists of 6 stages. Supervised and nonsupervised follow-up refer to assessment of outcome at or outside the participating center, respectively.

* Screening involves checking eligibility and ruling out secondary hypertension.
* Run-in period of 3 months to optimize medical treatment and to assess adherence to treatment.
* Stratification and randomization Eligible patients will be stratified by center and age group (adults vs. elderly, 20-49 vs. 50-69 years) and randomized centrally in a one-to-one proportion to control or intervention.
* Renal sympathetic denervation in the intervention group, patients of the control group will be offered renal denervation after 6 months.
* Supervised follow-up at 1, 3 and 6 months after randomization.
* Long-term supervised or non-supervised follow-up of morbidity and mortality beyond 6 months and up to 3 years.

Sample size:

To detect a 10-mm Hg difference (SD 20 mm Hg) in systolic blood pressure between the randomized groups with a 2-sided P-value of 0.01 and 90% power in total 240 patients need to be randomized. Allowing 50% screening failures, 480 patients would have to be screened.

Assessment of adherence:

Adherence to treatment will be assessed by measurement of drugs or drug metabolites in biological fluids. Jung and coworkers developed a liquid chromatography-mass spectrometric method that allows detecting all antihypertensive drugs or their metabolites in a single urine sample. This obligatory approach will be implemented.

Assessment of quality of life Assessment of quality of life is compulsory at baseline and at each visit during the supervised follow-up, using the EuroQol 5D.

Assessment of sympathetic modulation:

heart rate variability (HRV) will be assessed at baseline and at the 6-month follow-up visit, based on 15 minutes ECG recordings. A software program, developed in LabVIEW by the group of Aubert et al. will be used.

Relevance:

INSPiRED differs from previous and ongoing studies in several aspects: (1) a stringent selection of patients; (2) drug optimization with assessment of adherence throughout the study; (3) out-of-the-office blood pressure for patient selection and follow-up; (4) state-of-the-art renal artery imaging by computerized tomographic angiography; (5) validation of urinary proteomic biomarkers to predict blood pressure responses and changes in renal function; (6) follow-up will be beyond 6 months up to 3 years; (7) use of heart rate variability and renal nerve stimulation to assess the completeness of renal denervation.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Standard antihypertensive drug treatment

Group Type OTHER

Renal denervation

Intervention Type PROCEDURE

Renal denervation in the intervention group

Intervention group

Renal denervation plus standard antihypertensive drug treatment

Group Type EXPERIMENTAL

Renal denervation

Intervention Type PROCEDURE

Renal denervation in the intervention group

Interventions

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Renal denervation

Renal denervation in the intervention group

Intervention Type PROCEDURE

Other Intervention Names

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Renal denervation, using an intravascular catheter system

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No