Skip to main content
OpenTrials
Completed

NCT Number: NCT02078973

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nephropathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of medical research

Holstebro, 7500, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

15 mg tolvaptan

Drug

15 mg pr day for 1 day

Other names: Samsca

30 mg tolvaptan

Drug

30 mg pr day for 1 day

Other names: Samsca

45 mg tolvaptan

Drug

45 mg pr day for 1 day

Other names: Samsca

Placebo

Drug

1 tablet Unikalk pr day for 1 day

Other names: Unikalk

Primary outcomes

  1. CH2O

    Time frame: 5-6 Hours

    Measurement of H2O clearance at baseline, during and after L-NMMA infusion

Secondary outcomes

  1. Urine biomarkers(Aquaporins and Epithelial Sodium Channels γ)

    Time frame: 5-6 Hours

  2. Central and brachial blood pressure

    Time frame: 5-6 Hours

  3. Augmentation Index

    Time frame: 5-6 Hours

  4. Vasoactive Hormones( Angiotensin II, Aldosterone, Endothelin, Atrial Natriuretic Peptide, Brain Natriuretic Peptide, Arginin Vasopressin)

    Time frame: 5-6 Hours

  5. Fractional sodium excretion

    Time frame: 5-6 Hours

    Measurement of Sodium excretion at baseline, during and after L-NMMA infusion.

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study 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.

Acronym: DOVA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2014
Registry last updated
Mar 1, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.