Role of Adding Spironolactone and Renal Denervation in True Resistant Hypertension: One-Year Outcomes of Randomized PRAGUE-15 Study
Language English Country United States Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
26693818
DOI
10.1161/hypertensionaha.115.06526
PII: HYPERTENSIONAHA.115.06526
Knihovny.cz E-resources
- Keywords
- ambulatory blood pressure monitoring, blood pressure, renal denervation, resistant hypertension, spironolactone,
- MeSH
- Blood Pressure Monitoring, Ambulatory MeSH
- Angiography MeSH
- Time Factors MeSH
- Diuretics administration & dosage MeSH
- Echocardiography MeSH
- Hypertension diagnosis physiopathology therapy MeSH
- Blood Pressure physiology MeSH
- Kidney innervation MeSH
- Drug Resistance MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Tomography, X-Ray Computed MeSH
- Prospective Studies MeSH
- Spironolactone administration & dosage MeSH
- Sympathectomy methods MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Diuretics MeSH
- Spironolactone MeSH
This randomized, multicenter study compared the relative efficacy of renal denervation (RDN) versus pharmacotherapy alone in patients with true resistant hypertension and assessed the effect of spironolactone addition. We present here the 12-month data. A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomized to RDN and 54 patients to the spironolactone addition, with baseline systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. Twelve-month results are available in 101 patients. The intention-to-treat analysis found a comparable mean 24-hour systolic blood pressure decline of 6.4 mm Hg, P=0.001 in RDN versus 8.2 mm Hg, P=0.002 in the pharmacotherapy group. Per-protocol analysis revealed a significant difference of 24-hour systolic blood pressure decline between complete RDN (6.3 mm Hg, P=0.004) and the subgroup where spironolactone was added, and this continued within the 12 months (15 mm Hg, P= 0.003). Renal artery computed tomography angiograms before and after 1 year post-RDN did not reveal any relevant changes. This study shows that over a period of 12 months, RDN is safe, with no serious side effects and no major changes in the renal arteries. RDN in the settings of true resistant hypertension with confirmed compliance is not superior to intensified pharmacological treatment. Spironolactone addition (if tolerated) seems to be more effective in blood pressure reduction.
References provided by Crossref.org
Should All Patients with Resistant Hypertension Receive Spironolactone?
