Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR) (VAPANCR)
Primary Purpose
Renal Cancer, Nephrectomy, Blood Pressure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Renin measurement
Sponsored by
About this trial
This is an interventional prevention trial for Renal Cancer
Eligibility Criteria
Inclusion Criteria:
- Nephrectomy programmed for located renal cancer
Exclusion Criteria:
- Patients with metastatic renal cancer
- Incapacity to use a self-measurement tensiometer
- Patients treated for high blood pressure
- Patients with laxative
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients
Arm Description
Outcomes
Primary Outcome Measures
Blood pressure change
preoperative and postoperative measurements of blood pressure
Secondary Outcome Measures
Renal function
preoperative and postoperative measurements of renal function with measurements of renin activity and the glomerular filtration rate.
Cardiovascular risk
Study the occurence of cardiovascular risk after nephrectomy
Full Information
NCT ID
NCT03218319
First Posted
July 11, 2017
Last Updated
July 12, 2017
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT03218319
Brief Title
Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR)
Acronym
VAPANCR
Official Title
Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates the impact of nephrectomy in renal cancer on blood pressure and renal function. The patients will have a follow-up of their blood pressure and renal function until 6 months after their operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer, Nephrectomy, Blood Pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Renin measurement
Intervention Description
patients will have a blood sample for measuring renin activity
Primary Outcome Measure Information:
Title
Blood pressure change
Description
preoperative and postoperative measurements of blood pressure
Time Frame
One time before the operation and twice after : 1 month and 6 months
Secondary Outcome Measure Information:
Title
Renal function
Description
preoperative and postoperative measurements of renal function with measurements of renin activity and the glomerular filtration rate.
Time Frame
One time before the operation and one after 6 months
Title
Cardiovascular risk
Description
Study the occurence of cardiovascular risk after nephrectomy
Time Frame
A clinical exam will perform before the surgery and 1 month and 6 months after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nephrectomy programmed for located renal cancer
Exclusion Criteria:
Patients with metastatic renal cancer
Incapacity to use a self-measurement tensiometer
Patients treated for high blood pressure
Patients with laxative
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Bigot
Phone
+332 41 35 64 94
Email
PiBigot@chu-angers.fr
12. IPD Sharing Statement
Learn more about this trial
Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR)
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