Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD)

Hypertension Clinical Trial

— RenVas  

Official title:

The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380717
• Other study ID #: RenVas
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2011
• Last updated: February 26, 2014
• Start date: February 2011
• Est. completion date: February 2014

Study information

• Verified date: September 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Insufficiency
• Hypertension
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Vasodilation

Intervention

Drug:
• Beta-blocker, ACE-inhibitor
Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day
• Calcium Channel Blockers, ACE-Inhibitor
Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day

Locations

Country	Name	City	State
Denmark	Department of Renal Medicine, Aarhus University Hospital, Skejby	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glomerular filtration rate between the two treatment arms.		Measured at baseline and after 18 months of treatment	Yes
Secondary	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.		18 months	Yes