Cardiovascular Diseases | Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA)
Cardiovascular Diseases research study
What is the primary objective of this study?
The purpose of this study is to investigate the effect of tolvaptan on renal water, sodium and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure, pulse wave velocity (PWV) and augmentation index, basal and during inhibition of nitric oxide synthesis in healthy subjects.
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Tolvaptan15 mg pr day for 1 day
Drug:Placebo1 tablet Unikalk 1 pr day for 1 day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
TolvaptanOral administration of 15 mg Tolvaptan on each examination day.
PlaceboOral administration of 15 mg Unikalk tablet on each examination day.
Start Date: May 2012
Completed Date: March 2014
Phase: Phase 2
Primary Outcome: CH2O
Secondary Outcome: Urine biomarkers(Aquaporins, Epithelial Sodium Channels γ and β, Sodium/Chloride and Sodium/Potassium/Chloride cotransporter)
Study sponsors, principal investigator, and references
Principal Investigator: Safa Therwani, Bachelor
Lead Sponsor: Regional Hospital Holstebro