REducing Hypertension by bAriatric Surgery Handling (REHASH)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Ethicon Endo-Surgery

Information provided by (Responsible Party):

Hospital do Coracao

ClinicalTrials.gov Identifier:

NCT01784848

First received: February 4, 2013

Last updated: February 6, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 4, 2013
Last Updated Date	February 6, 2013
Start Date ^ICMJE	January 2013
Estimated Primary Completion Date	October 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 6, 2013)	reduction of hypertension medication prescription [ Time Frame: 12 months ] [ Designated as safety issue: No ] Reduce at least 30% of hypertension medication prescription related to the baseline hypertension treatment at 12 months after randomization.
Original Primary Outcome Measures ^ICMJE (submitted: February 5, 2013)	reduction of hypertension medication prescription [ Time Frame: 12 months ] [ Designated as safety issue: No ] Comparison between the two groups (clinical and surgery groups) proportion of > or equal 30% reduction of hypertension medication prescription related to the baseline hypertension treatment at 12 months after randomization.
Change History	Complete list of historical versions of study NCT01784848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 6, 2013)	reduction of hypertension medication prescription . [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ] to reduce at least 30% of hypertension medication prescription related to the baseline hypertension treatment at 6 and 24 months.
Original Secondary Outcome Measures ^ICMJE (submitted: February 5, 2013)	reduction of hypertension medication prescription . [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ] Comparison between the two groups (clinical and surgery groups) proportion of > or iqual 30% hypertension medication prescription related to the baseline hypertension treatment at 6 and 24 months.
Current Other Outcome Measures ^ICMJE (submitted: February 6, 2013)	absolute change from baseline in blood pressure levels [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] mean difference of change from baseline blood pressure levels using ambulatory blood pressure monitoring (ABPM)and using Sphygmomanometer blood pressure monitor absolute change from baseline in corporeal weight and body mass index. [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] absolute change from baseline in fasting plasm glucose level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] absolute change from baseline in HbA1c percentual [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] absolute change from baseline in insulin levels [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] absolute change from baseline in LDL-cholesterol level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] absolute change from baseline in HDL-cholesterol level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] absolute change from baseline in triglycerides level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] absolute change from baseline in anthropometric measurements [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] any adverse events [ Time Frame: 15 days, 1, 6, 12 and 24 months ] [ Designated as safety issue: Yes ] all adverse reactions reported during follow-up visits.
Original Other Outcome Measures ^ICMJE (submitted: February 5, 2013)	change from baseline values in blood pressure level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] mean difference of change from baseline blood pressure values using ambulatory blood pressure monitoring (ABPM)and using Sphygmomanometer blood pressure monitor change from baseline in corporeal weight and body mass index. [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] change from baseline fasting plasm glucose level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] change from baseline in HbA1c percentual [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] change from baseline in insulin level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] change from baseline in LDL-cholesterol level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] change from baseline in HDL-cholesterol level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] change from baseline in triglyceride level [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] change from baseline in antropometric measurements [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ] adverse events [ Time Frame: 15 days, 1, 6, 12 and 24 months ] [ Designated as safety issue: Yes ] all adverse reaction reported at least at all follow-up visits.

Descriptive Information
Brief Title ^ICMJE	REducing Hypertension by bAriatric Surgery Handling
Official Title ^ICMJE	Phase 3 Randomized Controlled Trial Evaluating the Effect of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on Hypertension Medication Reduction, Blood Pressure Levels and Others Cardiovascular Risk Factors.
Brief Summary	This is an unicentric phase 3 randomized controlled trial, with allocation concealment, intent-to-treat analysis and mask scheme at outcome assessors level, comparing the effect of Laparoscopic Roux En Y gastric bypass with best medical treatment on reduction of hypertension medications prescription. The study hypothesis is that gastric bypass is superior than the clinical treatment on reduction the number of hypertension medications. We also evaluate the effect of Laparoscopic Roux En Y gastric bypass on systemic hypertension levels and others cardiovascular risk factors.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Systemic Hypertension Obesity
Intervention ^ICMJE	Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB) Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery
Study Arm (s)	Experimental: Laparoscopic Roux-en-Y gastric bypass Laparoscopic Roux-en-Y gastric bypass is one of the techniques of bariatric surgery Intervention: Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB) Active Comparator: best hypertension clinical treatment best hypertension clinical treatment will be defined according to the principal investigator description Intervention: Procedure: Laparoscopic Roux-en-Y gastric bypass (LRYGB)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	October 2015
Estimated Primary Completion Date	October 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adults aged between 18 and 65 years old. hypertension diagnosis defined as in use of at least 2 high blood pressure medication at full doses. body mass index between 30,0 and 39,9 kg/m2. Exclusion Criteria: hypertension ≥ 180/120 mmHg; cerebrovascular diseases in the last 6 months. Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 6 months. Baseline psychiatric disorders: schizophrenia, bipolar disorder, severe depression, psychosis. Renal diseases: diabetic nephropathy, creatinine clearance < 30 ml/min. Patients with secondary hypertension except due to the sleep apnea. Advanced peripheral arterial disease atrophic gastritis Diabetes mellitus type 1 and type 2 with HbA1 c >7,0% alcoholism or use of illicit drugs smokers previous laparotomy severe hepatic disorders Pregnancy or women not using effective contraceptive methods. Recent neoplasm (< 5 years) Immunosuppressant drugs Unable to understanding and follow the study protocol orientations.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01784848
Other Study ID Numbers ^ICMJE	IEP2013_HAS
Has Data Monitoring Committee	No
Responsible Party	Hospital do Coracao
Study Sponsor ^ICMJE	Hospital do Coracao
Collaborators ^ICMJE	Ethicon Endo-Surgery
Investigators ^ICMJE	Not Provided
Information Provided By	Hospital do Coracao
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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