Comparison of renal sympathetic denervation with spironolactone in patients with still a high blood pressure despite the use of 3 different antihypertensive agents.

Endovascular renal sympathetic denervation versus spironolactone in treatment-resistant hypertension: A randomized, multicentric study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26106

Enrollment

120

Registered

2012-05-21

Start date

2012-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Hypertension, Renal sympathetic denervation, Sprionolactone. Hypertensie, Renale sympathische denervatie, spironolacton

Interventions

1. Endovascular renal sympathetic denervation

2. Addition of spironolactone to existing antihypertensive treatment. The intervention consists either of endovascular renal sympathetic denervation or the addition of spironolactone to existing anti

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 yrs and < 75 yrs; 2. Treatment-resistent hypertension; 3. Willingness to give informed written consent.

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension; 2. Renal arteries inaccessible for endovascular denervation; 3. Suboptimal dosing of BP lowering medication; 4. Incompliant to treatment; 5. White coat hypertension; 6. Pregnancy; 7. GFR < 45 ml/min; 8. Use of vit K antagonist that can not be discontinued for a short period; 9. Sprinolactone intolerance; 10. Intolerance for one of the components of Exforge-Hydrochlorothiazidee; 11. Myocardial infarction or cerebrovascular accident 3 months prior to randomization; 12. Life expectancy< 2 year.

Design outcomes

Primary

Measure	Time frame
Difference in 24-hour ambulatory blood pressure between spironolactone and endovascular renal denervation 6 months after intervention.	—

Secondary

Measure	Time frame
1. Proportion of patients with normalisation of ambulatory blood pressure in the two intervention groups; 2. Proportion of patients per intervention group with a decrease in 24-hour ambulatory blood pressure of at least 10 mmHg systolic and and at least 5 mmHg diastolic; 3. Predictive value of clonidin-suppression test on blood pressure response to endovascular sympathetic denervation; 4. Cost effectiveness of renal sympathetic denervation; 5. Difference in quality of life score between endovascular renal denervation and spironolactone group.	—

Measure

Time frame

1. Proportion of patients with normalisation of ambulatory blood pressure in the two intervention groups; 2. Proportion of patients per intervention group with a decrease in 24-hour ambulatory blood pressure of at least 10 mmHg systolic and and at least 5 mmHg diastolic; 3. Predictive value of clonidin-suppression test on blood pressure response to endovascular sympathetic denervation; 4. Cost effectiveness of renal sympathetic denervation; 5. Difference in quality of life score between endovascular renal denervation and spironolactone group.

—

Contacts

Public ContactA.H. Meiracker, van den

Erasmus MC

a.vandenmeiracker@erasmusmc.nl+31-10-4639222

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)