Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA)

Nephropathy Clinical Trial

— DOVA  

Official title:

The Effects of Tolvaptan on Renal Handling of Water and Sodium, Vasoactive Hormones and Circulatory System, During Basal Conditions and During Inhibition of the Nitric Oxide System in Healthy Subjects. A Dose-response Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078973
• Other study ID #: SAFA-1-2014
• Secondary ID: 2013-003800-38
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2014
• Last updated: February 28, 2017
• Start date: March 1, 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tolvaptan is a selective vasopressin receptor antagonist (V2R) that increases free water and sodium excretion. Inhibition of V2R increases vasopressin concentration in plasma, which stimulates V1-receptors in the vascular bed and may change both central and brachial hemodynamics and plasma concentration of vasoactive hormones.

The purpose of the study is to measure the effects of tolvaptan on renal handling of water and sodium, systemic hemodynamics and vasoactive hormones at baseline and during nitric oxide (NO)-inhibition with L-NG-monomethyl-arginine (L-NMMA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Men and women, age 18-40 years

• Body Mass Index (BMI) 18,5-30 kg/m2

Exclusion Criteria:

• Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease

• Neoplastic disease

• Drug abuse

• Alcohol abuse

• Medical treatment except peroral anticontraceptive

• Pregnancy

• Smoking

• Abnormal blood and urine sample

• Abnormal ECG

• Blood donation within a month before examination

• Arterial hypertension (>140 mmHg systolic and/or 90 mmHg diastolic)

Related Conditions & MeSH terms

• Nephropathy

Intervention

Drug:
• 15 mg tolvaptan
15 mg pr day for 1 day
• 30 mg tolvaptan
30 mg pr day for 1 day
• 45 mg tolvaptan
45 mg pr day for 1 day
• Placebo
1 tablet Unikalk pr day for 1 day

Locations

Country	Name	City	State
Denmark	Department of medical research	Holstebro

Sponsors (2)

Lead Sponsor	Collaborator
Regional Hospital Holstebro	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CH2O	Measurement of H2O clearance at baseline, during and after L-NMMA infusion	5-6 Hours
Secondary	Urine biomarkers(Aquaporins and Epithelial Sodium Channels ?)		5-6 Hours
Secondary	Central and brachial blood pressure		5-6 Hours
Secondary	Augmentation Index		5-6 Hours
Secondary	Vasoactive Hormones( Angiotensin II, Aldosterone, Endothelin, Atrial Natriuretic Peptide, Brain Natriuretic Peptide, Arginin Vasopressin)		5-6 Hours
Secondary	Fractional sodium excretion	Measurement of Sodium excretion at baseline, during and after L-NMMA infusion.	5-6 Hours