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

NCT06569589 | Recruiting

• 1 other identifier: 2023-1047
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hypertension; Primary Aldosteronism; Hypokalemia

Keywords

NaMRI; muscle Na+ quantification; K+ supplementation

Outcome Measures

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.

  Baseline

Secondary Outcomes (3)

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

  Baseline to 3 Months

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

  Baseline to 18 months

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

  36 Months

Study Arms (1)

Suspected PA

Age 21-70 years, with arterial hypertension or suspected to have primary aldosteronism based on Endocrine Society Guidelines.

Diagnostic Test: 23NaMRI Scan; Dietary Supplement: Potassium Chloride (KCl)

Interventions

23NaMRI Scan DIAGNOSTIC_TEST

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

Suspected PA

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

Suspected PA

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jens Titze: lead
• Changi General Hospital: collaborator
• Singapore General Hospital: collaborator
• Sengkang General Hospital: collaborator

Study Sites (4)

Singapore General Hospital

Singapore, 169608, Singapore

NOT YET RECRUITING

Duke NUS Medical School

Singapore, 169857, Singapore

RECRUITING

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

Sengkang General Hospital

Singapore, 544886, Singapore

NOT YET RECRUITING

Related Publications (3)

• Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schofl C, Renz W, Santoro D, Niendorf T, Muller DN, Neininger M, Cavallaro A, Eckardt KU, Schmieder RE, Luft FC, Uder M, Titze J. (23)Na magnetic resonance imaging of tissue sodium. Hypertension. 2012 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5.

  PMID: 22146510 BACKGROUND

• Kopp C, Linz P, Dahlmann A, Hammon M, Jantsch J, Muller DN, Schmieder RE, Cavallaro A, Eckardt KU, Uder M, Luft FC, Titze J. 23Na magnetic resonance imaging-determined tissue sodium in healthy subjects and hypertensive patients. Hypertension. 2013 Mar;61(3):635-40. doi: 10.1161/HYPERTENSIONAHA.111.00566. Epub 2013 Jan 21.

  PMID: 23339169 BACKGROUND

• Marton A, Saffari SE, Rauh M, Sun RN, Nagel AM, Linz P, Lim TT, Takase-Minegishi K, Pajarillaga A, Saw S, Morisawa N, Yam WK, Minegishi S, Totman JJ, Teo S, Teo LLY, Ng CT, Kitada K, Wild J, Kovalik JP, Luft FC, Greasley PJ, Chin CWL, Sim DKL, Titze J. Water Conservation Overrides Osmotic Diuresis During SGLT2 Inhibition in Patients With Heart Failure. J Am Coll Cardiol. 2024 Apr 16;83(15):1386-1398. doi: 10.1016/j.jacc.2024.02.020.

  PMID: 38599715 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Urine samples

MeSH Terms

Conditions

Hypertension; Hyperaldosteronism; Hypokalemia

Interventions

Potassium, Dietary

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Potassium Compounds; Inorganic Chemicals

Study Officials

• Jens Titze, MD

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzy Tiing Lim

CONTACT

+65 6516 7666; tzytiing.lim@duke-nus.edu.sg

Marton Adriana, MD

CONTACT

adriana.marton@duke-nus.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 26, 2024
• Study Start: December 27, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 2 years after article publication with no end date
• Access Criteria: Access will be granted upon reasonable request, provided that interested researchers have a scientific hypothesis for which they submit a methodologically sound proposal, including clearly defined research hypothesis and a statistical analysis plan.

Locations

SG (4)