Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569589
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Tissue Sodium Quantification in Patients With Primary Aldosteronism See Sodium to Treat
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tissue Sodium Quantification in Patients With Primary Aldosteronism
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SSTT
Brief Summary:
The study aims to provide quantitative facts on the pathophysiological changes in tissue Na content during NaK 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
Detailed Description:
Arterial hypertension is a major modifiable cardiovascular risk factor along with diabetes mellitus Hypertension due to autonomous elevation in aldosterone production Primary Aldosteronism PA is not responsive to usual antihypertensive medications and is dramatically underdiagnosed in standard clinical routine Currently only 01 1280000 worldwide and 1140 Singaporeans are diagnosed much lower than the 5-20 64000000-256000000 worldwide and 57000-228000 Singaporeans of all patients with arterial hypertension estimated to suffer from PA Given the high prevalence of PA low rates of diagnoses high cardiometabolic morbidity and mortality associated with untreated PA the detection of more patients with PA is obligatory and treatment success must be monitored
The investigators hypothesize that patients with primary aldosteronism have excessive Na storage in the muscle which can now be quantified non-invasively using 23NaMRI This study will be the first to systematically quantify changes in muscle Na stores in these patients in response to standard therapy There is currently no established clinical diagnostic tool to detect or quantify the underlying cellular NaK redistribution physiology in patients with PA Seeing and quantifying the Na non-invasively with 23NaMRI will provide a fresh look into the pathophysiological principles of solute and fluid homeostasis to evaluate therapy efficacy and to improve rates of PA diagnoses with an intention to cure
This is a prospective non-randomized multi-centre study with 3 study visits pre-potassium treatment pre- diagnosis and post-treatment over a study period of 3 years Approximately 100 participants will be recruited from hospital sites The purpose of the study is to detect and quantify a hidden pathophysiological NaK redistribution process at the tissue level using 23NaMRI in an effort to provide an alternative to traditional hormone and solute diagnostics in blood and urine
The investigators hypothesize that patients with primary aldosteronism have excessive Na storage in the muscle which can now be quantified non-invasively using 23NaMRI This study will be the first to systematically quantify changes in muscle Na stores in these patients in response to standard therapy There is currently no established clinical diagnostic tool to detect or quantify the underlying cellular NaK redistribution physiology in patients with PA Seeing and quantifying the Na non-invasively with 23NaMRI will provide a fresh look into the pathophysiological principles of solute and fluid homeostasis to evaluate therapy efficacy and to improve rates of PA diagnoses with an intention to cure
This is a prospective non-randomized multi-centre study with 3 study visits pre-potassium treatment pre- diagnosis and post-treatment over a study period of 3 years Approximately 100 participants will be recruited from hospital sites The purpose of the study is to detect and quantify a hidden pathophysiological NaK redistribution process at the tissue level using 23NaMRI in an effort to provide an alternative to traditional hormone and solute diagnostics in blood and urine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None