Role of renal and systemic vascular resistance for progression of chronic kidney disease - RenVas

Conditions: We want to investigate whether increased vasodilitation ( angiotensin converting enzyme inhibitor and calcium channel blocker) compared to standard treatment ( beta-blocker and angiotensin converting enzyme inhibitor) reduces the rate of decline of GFR in patients with chronic kidney disease (grade 3 to 4) and hypertension.Patients with ischemic heart disease or congestive heart failure will be treated with Carvedilol if randomized to increased Vasodilitation.
MedDRA version: 13.1Level: LLTClassification code 10063097Term: Peripheral vasodilatationSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 13.1Level: PTClassification code 10047141Term: VasodilatationSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-023979-25-DK

Lead Sponsor: Department of Nephrology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

CKD grade 3-4
Hypertension (Blood pressure > 130/80 measured 24 h ambulatory)
Age> 18 years
Fertile women: Must have safe contraception
Informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Claustrophobia in a degree which makes MRI impossible
Ultrasound verified polycystic kidney disease
Pregnancy or wish to be pregnant
Contraindications to MRI (Pacemaker, metal implants incompatible with MRI)
Allergy to the medicine used in the trail
Blood pressure blow 130/80 (24 h ambulatory) without antihypertensive drugs
Blood pressure over 130/80 (24h ambulatory) while treatmented with maximum dose of beta-blocker, ACEi and CCB simultaneously.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does increased vasodilation reduce loss of kidney function in patients with CKD grad 3-4 and hypertension.;Secondary Objective: Will increased vasodilation normalize the structure of resistance vessels in patients with CKD grade 3-4 and hypertension. ;Primary end point(s): Difference in decline of GFR (glomerular filtation rate) in the two treatment arms.<br><br>

Secondary Outcome Measures