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Trial · NCT07020104

Registered outcomes40

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySkin sodium content at baseline (A)0 weekSkin sodium content will be measured using the 7T sodium MRI
PrimaryMuscle sodium content at baseline (A)0 weekMuscle sodium content will be measured using the 7T sodium MRI
PrimaryChange from baseline in tissue sodium content after low and high sodium diet (B)2 weeks
PrimaryChange in tissue sodium content after treatment with hydrochloorthiazide, spironolacton and lercanidipine (C)6 weeks
To study the effect of hydrochloorthiazide, spironolacton and lercanidipine on tissue sodium content, to compare the effect among the various antihypertensive agents and to assess the effect of blood pressure regulation, increased renal sodium excretion and aldosteron blockade on tissue sodium content.
PrimaryChange from baseline in tissue sodium content after habitual and high water intake (D)4 weeksTo evaluate the effect of high and habitual water intake on tissue sodium content.
PrimaryChange from baseline in transepidermal water loss after habitual and high water intake (D)4 weeksTo evaluate the effect of high and habitual water intake on transepidermal water loss.
PrimaryIncidence of hyponatremia and hypervolemia (D)4 weeksSafety of high water intake in CKD patients with eGFR between 15 and 30ml/min/1.73m2
SecondaryCorrelation between tissue sodium content and total vessel density (A)0 weekCorrelation between tissue sodium content measured with 7T Na-MRI and total vessel density using Sidestream Dark Field imaging.
SecondaryCorrelation between tissue sodium content and perfused vessel density (A)0 weekCorrelation between tissue sodium content measured with 7T Na-MRI and perfused vessel density using Sidestream Dark Field imaging.
SecondaryCorrelation between tissue sodium content and proportion of perfused vessels (A)0 weekCorrelation between tissue sodium content measured with 7T Na-MRI and proportion of perfused vessels using Sidestream Dark Field imaging.
SecondaryCorrelation between tissue sodium content and microvascular flow index (A)0 weekCorrelation between tissue sodium content measured with 7T Na-MRI and microvascular flow index using Sidestream Dark Field imaging.
SecondaryCorrelation between tissue sodium content and microvascular health score (A)0 weekCorrelation between tissue sodium content measured with 7T Na-MRI and microvascular health score using Sidestream Dark Field imaging.
SecondaryCorrelation between tissue sodium content and total pheripheral resistance (A)0 weekTotal pheripheral resistance will be measured using the Nexfin device and tissue sodium content will be measured using the 7T Na-MRI
SecondaryCorrelation between tissue sodium content and cardiac output (A)0 weekCardiac output will be measured using the Nexfin device and tissue sodium content will be measured using the 7T Na MRI
SecondaryCorrelation between tissue sodium content and transepidermal water loss (A)0 weekTransepidermal water loss will be measured with the Tewameter® TM Hex probe and tissue sodium content will be measured using the 7T Na MRI
SecondaryCorrelation between tissue sodium content and office systolic and diastolic blood pressure (A)0 weekTissue sodium content will be measured using the 7T sodium MRI
SecondaryCorrelation between tissue sodium content and 24-hour systolic and diastolic blood pressure (A)0 weekTissue sodium content will be measured using the 7T Na MRI
SecondaryCorrelation between tissue sodium content and nightime blood pressure dipping pattern (A)0 week
The nighttime blood pressure dipping pattern will be measured with a 24-hour blood pressure measurements. Patients will be classified as a 'dippers' when the nighttime systolic blood pressure and/or diastolic blood pressure falls \>10% and \<20% compared to daytime readings. Exteme dippers are described as those with blood pressure fall of at least 20%. Patients with blood pressure fall between 0 and 10% are classified as non-dippers.
SecondaryCorrelation between tissue sodium content and total body water (A)0 weekTotal body water (liter) will be measured using the bioelectrical impendance analysis and tissue sodium content will be measured using the 7T Na MRI
SecondaryCorrelation between tissue sodium content and quality of life (A)At baseline and yearly during follow-up
Quality of life(QoL) will be measured with the Kidney Disease Quality of Life questionnaire at baseline and yearly during follow-up and tissue sodium comntent will be measured using the 7T Na MRI at baseline

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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