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Endovascular renal sympathetic denervation versus spironolactone for treatment-resistant hypertension: a randomized, multicentric study

Endovascular renal sympathetic denervation versus spironolactone for treatment-resistant hypertension: a randomized, multicentric study - RRSS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37880
Enrollment
130
Registered
2011-12-09
Start date
2012-07-03
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertensie High blood pressure Hypertension

Interventions

RFSD or addition of spironolacton in a maximal dose of 50 mg per day. Per treatment arm 47 evaluable patients are needed. Follow-up duration after intervention is 6 months.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 75 yrs Treatment-reistant hypertension Willingness to give written informed consent

Exclusion criteria

Exclusion criteria: Secondary forms of hypertension Renal arteries not accessible to intervention Suboptimal dosing of anthypertensive medication White coat hypertension Pregnancy Renal insufficiency (GFR

Design outcomes

Primary

MeasureTime frame
Difference in 24-hour ambulatory blood pressure decrease between the RFSD and spironolactone group.

Secondary

MeasureTime frame
- Proportion of patients per intervention group with normalization of their 24-hour ambulatory blood pressure - Proportion of patients per intervention group with a decrease in 24-hour ambulatory blood pressure of >= 10 mmHg systolic and >= 5 mmHg diastolic. - Cost effective of RFSD - Difference in scores of quality of llife between RFSD and spironolactone group - Predictive value of clonidine-suppressiontest for the blood pressure response to RFSD

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)