Table 2

Key lessons from Symplicity HTN-3

Lesson	Recommendations for the future
Hypertension specialists were not involved in most centres Antihypertensive medications stability is critical Study entry During study	Routine use of multidisciplinary teams led by accredited hypertension specialist Hypertension specialists should design the clinical trials in conjunction with scientists and interventionalists Stable medication regimen for at least 8 weeks prior to study entry or use of optimised medical regimen with washout period of 4 weeks prior to baseline if feasible and forced titration during study (does not necessarily apply to trials of RHTN) Maintain stable medications throughout study per protocol: strict criteria for clinically necessary medication changes
Heterogeneous study population differed from prior trials of RDN with more African-Americans Procedural factors Operator supervision Operator experience	Study subjects should reflect the population of resistant hypertensives—it is entirely appropriate to recruit all ethnicities as black ethnicity is a risk factor for RHTN Adequate proctoring for inexperienced operators Ensure delivery of adequate ablations per artery Ensure 4 quadrant delivery of ablation Assume learning curve of at least 10 procedures with each RDN system

Lesson

Recommendations for the future

Hypertension specialists were not involved in most centres

Antihypertensive medications stability is critical

Study entry
During study

Routine use of multidisciplinary teams led by accredited hypertension specialist
Hypertension specialists should design the clinical trials in conjunction with scientists and interventionalists

Stable medication regimen for at least 8 weeks prior to study entry or use of optimised medical regimen with washout period of 4 weeks prior to baseline if feasible and forced titration during study (does not necessarily apply to trials of RHTN)
Maintain stable medications throughout study per protocol: strict criteria for clinically necessary medication changes

Heterogeneous study population differed from prior trials of RDN with more African-Americans
Procedural factors

Operator supervision
Operator experience

Study subjects should reflect the population of resistant hypertensives—it is entirely appropriate to recruit all ethnicities as black ethnicity is a risk factor for RHTN

Adequate proctoring for inexperienced operators
Ensure delivery of adequate ablations per artery
Ensure 4 quadrant delivery of ablation
Assume learning curve of at least 10 procedures with each RDN system

RDN, renal denervation; RHTN, Resistant Hypertension.