Health TrialsbyHealthPanel

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

ConditionsHypertensionPrimary AldosteronismHypokalemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-70
SponsorJens Titze

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Approximately 100 patients with hypertension with accompanying hypokalemia will be recruited from hospital sites.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 23NaMRI Scan

    Diagnostic test

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

  • Potassium Chloride (KCl)

    Dietary supplement

    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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Suspected PA2 interventions

Trial outcomes

Primary outcomes

1

Patients with primary aldosteronism have a 10-20% higher muscle Na+ content compared to healthy controls

Difference in muscle Na+ content as measured with 23NaMRI between patients with PA and healthy controls at baseline.

Time frame
Baseline

Secondary outcomes

1

High K+ intake reduces muscle Na+ in patients with primary aldosteronism

Change in muscle Na+ content as measured with 23NaMRI, 3 months after initiation of K+ supplementation

Time frame
Baseline to 3 Months
2

MR blockade reduces muscle Na+ conten in patients with primary aldosteronism

Change in muscle Na+ content as measured with 23NaMRI, 12-18 months after initiation of MR blockade treatment

Time frame
Baseline to 18 months
3

Compared to MR blockade, adenoma surgical removal is more efficient in reducing muscle Na+ in patients with primary aldosteronism

Change in muscle Na+ content as measured with 23NaMRI after adenoma surgical removal compared to MR blockade treatment.

Time frame
36 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jens Titze

Lead sponsor

Duke-NUS Graduate Medical School

Sponsor institution

Changi General Hospital

Collaborator

Singapore General Hospital

Collaborator

Sengkang General Hospital

Collaborator

Source ClinicalTrials.gov
Apply now