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Prevention And Treatment of Hypertension With Algorithm-based therapy (PATHWAY) number 2: protocol for a randomised crossover trial to determine optimal treatment for drug-resistant hypertension.

Williams B, MacDonald TM, Caulfield M, Cruickshank JK, McInnes G, Sever P, Webb DJ, Salsbury J, Morant S, Ford I, Brown MJ - BMJ Open (2015)

Bottom Line: A key secondary outcome is to determine whether plasma renin predicts the BP response to the different drugs.The study can also detect a 6 mm Hg difference in HBPM average systolic BP between each patient's best and second-best drug predicted by tertile of plasma renin.The study was initiated in May 2009 and results are expected in 2015.

View Article: PubMed Central - PubMed

Affiliation: Institute of Cardiovascular Sciences University College London (UCL) and National Institute for Health Research (NIHR) UCL/UCL Hospitals Biomedical Research Centre, London, UK.

No MeSH data available.


Related in: MedlinePlus

PATHWAY 2 study design and flow chart.
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BMJOPEN2015008951F1: PATHWAY 2 study design and flow chart.

Mentions: After a screening visit, patients potentially eligible for randomisation proceeded to a 4-week run-in period on the patient's baseline therapy with three drugs, that is, A+C+D. After the run-in period and if still meeting the eligibility criteria, the patients were allocated double blind to a cycle of 4×once daily oral treatments in a random sequence. The randomisation is not stratified and in this 4 × 12-week period, four treatments crossover study, participants are randomised with equal probability to one of the 24 possible sequences of treatments. The treatments comprise: (1) further diuretic therapy—spironolactone; 25–50 mg, (2) α-blocker—doxazosin modified release; 4–8 mg, (3) β-blocker—bisoprolol; 5–10 mg and (4) placebo. The treatment cycles were initiated with each treatment for 6 weeks at the lower dose, followed by forced titration to twice this dose for a further 6 weeks—each cycle for a total of 12 weeks. There is no washout period between the four treatment cycles (3 active, 1 placebo), as 12 weeks of treatment per drug cycle is considered sufficient to eliminate the order effects of treatment. The total length of the trial is 52 weeks (4 weeks run-in and 4×12 week treatment cycles; figure 1).


Prevention And Treatment of Hypertension With Algorithm-based therapy (PATHWAY) number 2: protocol for a randomised crossover trial to determine optimal treatment for drug-resistant hypertension.

Williams B, MacDonald TM, Caulfield M, Cruickshank JK, McInnes G, Sever P, Webb DJ, Salsbury J, Morant S, Ford I, Brown MJ - BMJ Open (2015)

PATHWAY 2 study design and flow chart.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4538257&req=5

BMJOPEN2015008951F1: PATHWAY 2 study design and flow chart.
Mentions: After a screening visit, patients potentially eligible for randomisation proceeded to a 4-week run-in period on the patient's baseline therapy with three drugs, that is, A+C+D. After the run-in period and if still meeting the eligibility criteria, the patients were allocated double blind to a cycle of 4×once daily oral treatments in a random sequence. The randomisation is not stratified and in this 4 × 12-week period, four treatments crossover study, participants are randomised with equal probability to one of the 24 possible sequences of treatments. The treatments comprise: (1) further diuretic therapy—spironolactone; 25–50 mg, (2) α-blocker—doxazosin modified release; 4–8 mg, (3) β-blocker—bisoprolol; 5–10 mg and (4) placebo. The treatment cycles were initiated with each treatment for 6 weeks at the lower dose, followed by forced titration to twice this dose for a further 6 weeks—each cycle for a total of 12 weeks. There is no washout period between the four treatment cycles (3 active, 1 placebo), as 12 weeks of treatment per drug cycle is considered sufficient to eliminate the order effects of treatment. The total length of the trial is 52 weeks (4 weeks run-in and 4×12 week treatment cycles; figure 1).

Bottom Line: A key secondary outcome is to determine whether plasma renin predicts the BP response to the different drugs.The study can also detect a 6 mm Hg difference in HBPM average systolic BP between each patient's best and second-best drug predicted by tertile of plasma renin.The study was initiated in May 2009 and results are expected in 2015.

View Article: PubMed Central - PubMed

Affiliation: Institute of Cardiovascular Sciences University College London (UCL) and National Institute for Health Research (NIHR) UCL/UCL Hospitals Biomedical Research Centre, London, UK.

No MeSH data available.


Related in: MedlinePlus