Study design, patient characteristics of parallel group studies of renal denervation versus control in resistant hypertension
| Design | Year | Country | Number of participants (treatment, control) | Mean age | Per cent male | Selection criteria and management | |
|---|---|---|---|---|---|---|---|
| Clinical trials | |||||||
| Pokushalov et al12 | Randomised trial | NA | Russia, The Netherlands and USA | 27 (13, 14) | 56 and 57 years | 78 | Drug-refractory AF or paroxysmal AF, with BP ≥160 mm Hg (≥150 mm Hg with type 2 diabetes) with at least 3 antihypertensive drugs and eGFR ≥45 mL/min/1.73m2. Diuretics were used in 96% of patients. Patients with secondary causes of hypertension were excluded |
| SYMPLICITY HTN-27 | Randomised trial | June 2009 to January 2010 | Europe, Australia and New Zealand | 106 (52, 54) | 58 years | 58 | Age >18 years with BP ≥160 mm Hg (≥150 mm Hg with type 2 diabetes) with at least 3 antihypertensive drugs. Diuretics were used in 90% of patients. Patients with significant renal artery stenosis or renal artery anatomy that precluded treatment were excluded |
| SYMPLICITY HTN-38 9 | Randomised trial | September 2011 to January 2014 | International | 535 | 57 years | 61 | Age ≥18 and ≤80 years on stable medical regimen of ≥3 antihypertensives. Office BP ≥160 mm Hg on average of 3 readings on initial screening and confirmatory screening. Exclusions: eGFR<45 mL/min/1.73 m2, ambulatory blood pressure monitoring average <135 mm Hg, type 1 diabetes, chronic oxygen support, mechanical ventilation, primary pulmonary hypertension or pregnancy |
| Observational studies | |||||||
| Brandt et al14 | Prospective observational study | October 2009 to January 2011 | Austria and Germany | 64 (46, 18) | 63 years in both groups | 67 and 61 | Patients age >18 years with BP ≥160 mm Hg (≥150 mm Hg with type 2 diabetes) with at least 3 antihypertensive drugs. All patients were on diuretic treatment. Patients with secondary causes of hypertension were excluded |
| Brandt et al15 | Prospective observational study | October 2009 to September 2011 | Austria and Germany | 120 (110, 10) | 64 and 65 years | 70 and 80 | Patients age >18 years with BP ≥160 mm Hg (≥150 mm Hg with type 2 diabetes) with at least 3 antihypertensive drugs. Diuretics were used in 83% of patients. Patients with secondary causes of hypertension were excluded |
| Fatum et al16 | Prospective observational study | NA | Germany | 21 (15, 6) | 67 and 61 years | 59 and 60 | Patients age >18 years with BP ≥160 mm Hg (≥150 mm Hg with type 2 diabetes) with at least 3 antihypertensive drugs. Unclear use of diuretics. Unclear if patients with secondary causes of hypertensions were included |
| Franzen et al13 | Prospective observational study | NA | Germany | 27 (21, 6) | 63 years | NA | Patients with BP ≥150 mm Hg with at least 3 antihypertensive drugs. All patients were on diuretic treatment. Patients with secondary causes of hypertensions were excluded |
| Krum et al6 | Prospective observational study | June 2007 to November 2008 | Australia and Europe | 50 (45, 5) | 57 years | 58 | Patients age >18 years with BP ≥160 mm Hg (≥150 mm Hg with type 2 diabetes) with at least 3 antihypertensive drugs. Diuretics were used in 96% of patients. Patients with secondary causes of hypertensions were excluded |
| Lambert et al20 | Observational study with match controls | NA | Australia | 62 treatment, 248 controls | 62 years | 65 | Patients with resistant hypertension. Diuretics were used in 85% of patients. Unclear if patients with secondary causes of hypertension were excluded |
| Mahfoud et al17 | Prospective observational study | March 2009 to May 2010 | Australia and Germany | 50 (37, 13) | 60 years | 74 | Patients with age >18 years with BP ≥160 mm Hg (≥150 mm Hg with type 2 diabetes) with at least 3 antihypertensive drugs. All patients were taking diuretics. Patients with renal artery abnormality or stenosis were excluded |
| Mahfoud et al18 | Prospective observational study | January 2010 to February 2011 | Australia and Germany | 100 (88, 12) | 62 years | 61 | Patients with age >18 years with BP ≥160 mm Hg (≥150 mm Hg with type 2 diabetes) with at least 3 antihypertensive drugs. All patients had received diuretics. Patients with renal artery abnormality or stenosis were excluded |
| Ukena et al19 | Prospective observational study | March 2009 to October 2010 | Germany, Australia, USA | 46 (37, 9). 28 from SYMPLICITY HTN-2 | 60 years | 70 | Patients with age >18 years with BP ≥160 mm Hg (≥150 mm Hg with type 2 diabetes) with at least 3 antihypertensive drugs. Diuretics were used in 87% of patients. Patients with secondary causes of hypertension were excluded |
AF, atrial fibrillation; BP, blood pressure; eGFR, estimated-glomerular filtration rate; NA, not available.