Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2011-05-31
2012-02-29
Brief Summary
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Detailed Description
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This pilot study required patients to remain in hospital for one week during which they had careful monitoring of blood pressure with the ability to halt the trial if any patient suffered any dangerous effect such as a large drop in blood pressure. It also monitored blood pressure after discharge for six months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Renal denervation
renal denervation
Renal denervation
Renal denervation
Interventions
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Renal denervation
Renal denervation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* An estimated glomerular filtration rate \<35 ml/min
* Unfavourable renal anatomy
* Tortuous femoral arteries were not eligible
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Darrel P Francis, MD
Role: STUDY_CHAIR
Imperial College London
Justin E Davies, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
References
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Shun-Shin MJ, Howard JP, Francis DP. Removing the hype from hypertension. BMJ. 2014 Mar 6;348:g1937. doi: 10.1136/bmj.g1937. No abstract available.
Howard JP, Cole GD, Sievert H, Bhatt DL, Papademetriou V, Kandzari DE, Davies JE, Francis DP. Unintentional overestimation of an expected antihypertensive effect in drug and device trials: mechanisms and solutions. Int J Cardiol. 2014 Mar 1;172(1):29-35. doi: 10.1016/j.ijcard.2013.12.183. Epub 2014 Jan 8.
Davies JE, Manisty CH, Petraco R, Barron AJ, Unsworth B, Mayet J, Hamady M, Hughes AD, Sever PS, Sobotka PA, Francis DP. First-in-man safety evaluation of renal denervation for chronic systolic heart failure: primary outcome from REACH-Pilot study. Int J Cardiol. 2013 Jan 20;162(3):189-92. doi: 10.1016/j.ijcard.2012.09.019. Epub 2012 Sep 29.
Other Identifiers
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ICCH-10/065
Identifier Type: -
Identifier Source: org_study_id
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