RecruitingNCT06569589

Tissue Sodium Quantification in Patients With Primary Aldosteronism: See Sodium to Treat

Tissue Sodium Quantification in Patients With Primary Aldosteronism

Sponsor

Jens Titze

Enrollment

80 participants

Start Date

Dec 27, 2023

Study Type

OBSERVATIONAL

Conditions

Hypertension Primary Aldosteronism Hypokalemia

Summary

The study aims to provide quantitative facts on the pathophysiological changes in tissue Na+ content during Na+/K+ redistribution disorders in patients with PA in response to standard therapy. The investigators hypothesize that patients with primary aldosteronism have excessive Na+ storage in the muscle, which can now be quantified non-invasively using 23NaMRI. In analogy to the role of HbA1c as a metabolic long-term marker in diabetes, the quantifiable changes in muscle Na+ content may deliver the data evidence necessary to justify and conduct randomized diagnostic endpoint outcome trials in the future, with the ultimate aim to improve PA detection rate and treatment.

Eligibility

Min Age: 21 YearsMax Age: 70 Years

Inclusion Criteria3

Age 21-70 years, with arterial hypertension or suspected to have primary aldosteronism based on Endocrine Society Guidelines.
Male and female patients older than 21 years.
Willingness to participate and ability to provide informed consent.

Exclusion Criteria11

implanted devices (surgical clips, heart pacemakers or defibrillators, cochlear implants)
iron-based tattoos
any other pieces of metal or devices that are not MR-Safe anywhere in the body
patients who exhibit noticeable anxiety and/or claustrophobia into the MRI scanner
pregnancy
Diagnosis of heart failure NYHA classes III and IV
Impaired renal function with eGFR\<30 ml/min or proteinuria \> 1 g/24h
Liver disease with cirrhosis (Child-Pugh class C) or hypoalbuminemia
Muscular dystrophies
Patients with active cancer or severe comorbid conditions likely to compromise survival or study participation
Unwillingness or other inability to cooperate

Interventions

DIAGNOSTIC_TEST23NaMRI Scan

23NaMRI, a non-invasive detection and quantification of hidden tissue Na+ stores in humans.

DIETARY_SUPPLEMENTPotassium Chloride (KCl)

K+ supplementation intervention is given participants as part of their standard care. In this trial the K+ supplementation dosage is standardized and adjusted based on blood K+ level