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. 2014 Nov 27;101(1):10–16. doi: 10.1136/heartjnl-2014-307029

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

RDN, renal denervation; RHTN, Resistant Hypertension.