- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01380717
Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD) (RenVas)
The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease
Patients with reduced kidney function have a higher risk of heart disease and death. Studies have shown that blood vessels in patients with hypertension change with a decrease of lumen size and growth of the vessel wall. By treating patients with antihypertensive certain medication vessel lumen and walls normalize. Treating hypertension in patients with chronic kidney disease slows the progression of kidney function loss.
The aim is to compare different degrees of antihypertensive medication in patients with chronic kidney disease and hypertension will slow the progression of kidney loss.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Aarhus N, Denmark, 8200
- Department of Renal Medicine, Aarhus University Hospital, Skejby
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- eGFR 15-60 ml/min for at least 3 months
- Blood pressure > 130 mmHg systolic og >80 mmHg diastolic (patients without antihypertensive treatment or in treatment with Beta-blockers, ACEi, ARBs or CCB not in maximum dosi).
- Blood pressure < 130 mmHg systolic og < 80 mmHg diastolic (patients receiving Beta-blockers, ACEi, ARBs og CCB).
- Fertile women using safe contraceptives
Exclusion Criteria:
- Ultrasound verified Polycystic Kidney Disease (ADPKD)
- Claustrophobia (MRi scan).
- Contraindications to MRi.
- Pregnancy or wish to become pregnant in the study period.
- Nephrotic syndrome with gross edema.
- Known allergy to any study medication.
- Blood pressure < 130 mmHg systolic or < 80 mmHg diastolic without antihypertensive treatment.
- Blood pressure > 130 mmHg systolic or > 80 mmHg diastolic and in maximum dosages of all three Beta-blockers, ACEi (ARBs) and CCB.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard treatment
Patients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB.
|
Beta-blocker: 50- 100 mg 1-2 times a day.
ACEi: 5-10 mg once a day
|
Active Comparator: Intensive vasodilation
Patients with CKD 3-4 and hypertension, randomized to treatment with calcium channel blocker and if needed ACE-inhibitor or ARB for 18 months
|
Calcium Channel Blockers: 5-10 mg a day.
ACEi: 5-10 mg a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in glomerular filtration rate between the two treatment arms.
Time Frame: Measured at baseline and after 18 months of treatment
|
Measured at baseline and after 18 months of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in glomerular filtration rate stratified after changes in pulse wave velocity, renal vascular resistance and forearm minimal resistance at baseline and after 18 months of treatment.
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Niels Henrik Buus, DrMedSc, Department og Renal Medicine, Aarhus University Hospital, Skejby
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Renal Insufficiency
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium
- Calcium Channel Blockers
- Adrenergic beta-Antagonists
- Angiotensin-Converting Enzyme Inhibitors
Other Study ID Numbers
- RenVas
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
Clinical Trials on Beta-blocker, ACE-inhibitor
-
Uppsala UniversityKarolinska Institutet; Oslo University Hospital; Göteborg University; New York... and other collaboratorsTerminatedMyocardial Infarction With Non-obstructive Coronary ArteriesNorway, Sweden, Australia, New Zealand, Spain
-
Medical University InnsbruckLudwig-Maximilians - University of Munich; Deutsches Zentrum für Herz-Kreislauf-Forschung...Completed
-
Yonsei UniversityCompletedOrthognathic SurgeryKorea, Republic of
-
Università Vita-Salute San RaffaeleCompleted
-
Soroka University Medical CenterCompletedRadiographic Contrast Agent Nephropathy
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Uterine Corpus Carcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Endometrial Undifferentiated Carcinoma | Endometrial Adenocarcinoma | Endometrial Transitional Cell Carcinoma | Endometrial Mucinous Adenocarcinoma | Endometrial Mixed Adenocarcinoma | Endometrial...United States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal CarcinomaUnited States
-
University of Wisconsin, MadisonCompletedCardiovascular Disease | Chronic Kidney DiseaseUnited States
-
McGill UniversityMcGill University Health Centre/Research Institute of the McGill University... and other collaboratorsTerminated
-
Johns Hopkins UniversityTerminatedCardiac Valve Replacement | Cardiac Surgery-CABGUnited States