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Completed

NCT Number: NCT01380717

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

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.

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Key information

Conditions

Chronic Kidney Insufficiency Aneurysm Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vasodilation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Renal Medicine, Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beta-blocker, ACE-inhibitor

Drug

Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day

Calcium Channel Blockers, ACE-Inhibitor

Drug

Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day

Primary outcomes

  1. Change in glomerular filtration rate between the two treatment arms.

    Time frame: Measured at baseline and after 18 months of treatment

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: RenVas

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 27, 2011
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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