Investigating Salt Taste Threshold in Patients Being Investigated for Primary Hyperaldosteronism Before and After Treatment. (AldoSalt)
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|ClinicalTrials.gov Identifier: NCT04556279|
Recruitment Status : Unknown
Verified September 2020 by Imperial College London.
Recruitment status was: Not yet recruiting
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
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This study looks at how hypertensive patients, with high levels of aldosterone (hyperaldosteronism) differ from hypertensive patients without hyperaldosteronism with regards to markers of salt appetite. It also looks at how salt appetite changes after treatment of hyperaldosteronism. Salt makes food taste good and when our bodies need salt our brains make us like salty food even more. A high salt diet contributes to hypertension and a low salt diet is an important aspect of the treatment of hypertension. Unfortunately patients find it difficult to adhere to a low salt diet. Aldosterone is produced by the adrenal glands, its release is stimulated by a salt need and it has been shown, in rodent models, to activate pathways in the brain which drive a salt appetite. Mice with enhanced activity of the aldosterone pathway in the brain become hypertensive due to increased salt intake. Hyperaldosteronism, in humans, results in hypertension. The contribution of salt appetite, as opposed to the effect of aldosterone on the kidney's retention of salt and other systems, is unknown. Human studies have shown that when a human has a salt appetite, the concentration at which they can detect the taste of salt reduces, they increase their preference for salty food, and they consume more salt.
When hyperaldosteronism is suspected in a hypertensive patient, they attend hospital for a day of investigations. Patient who are shown to have hyperaldosteronism have subsequent visits for imaging of their adrenals and sampling of blood from the adrenal vein to diagnose aldosterone producing adenomas (small tumours) which may be removed surgically, if not suitable for surgery, the hyperaldosteronism is treated with medication. This study will recruit hyperaldosteronism patients to investigate the effect of aldosterone on salt appetite by testing salt taste threshold, salt taste preference and intake before and after treatment.
|Condition or disease||Intervention/treatment|
|Hyperaldosteronism; Primary Hypertension Salt; Excess Appetite Disorders||Procedure: adrenalectomy Drug: Aldosterone Antagonist|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Investigating Salt Taste Threshold in Patients Being Investigated for Primary Hyperaldosteronism Before and After Treatment.|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||March 2022|
hyperaldosteronism surgical treatment
Hypertensive patients with primary hypersldosteronism, treated with surgery
Surgical removal of an adrenal gland containing an aldosterone secreting adenoma.
Other Name: aldosterone blockade
hyperaldosteronism medical treatment
Hypertensive patients with primary hypersldosteronism, treated with aldosterone blockade.
Drug: Aldosterone Antagonist
Medical treatment of primary hyperaldosteronism.
Hypertensive patients shown not to have primary hyperaldosteronism
- Salt concentration taste threshold [ Time Frame: 6 months ]Concentration of saline at which the salt taste is detected.
- Ratings of salt liking and intensity across different salt concentrations [ Time Frame: 6 months ]ratings of liking/wanting and intensity of soup containing differing concentrations of salt.
- Rating of sweet liking and intensity [ Time Frame: 6 months ]ratings of liking/wanting and intensity of a sweet taste.
- Rating of sour liking and intensity [ Time Frame: 6 months ]rating of liking/wanting and intensity of a sour taste.
Biospecimen Retention: Samples Without DNA
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Aged 18-65 years
- Non-smoker (ex-smokers allowed)
- Contra-indications for saline infusion test - severe uncontrolled hypertension, renal insufficiency, cardiac insufficiency, cardiac arrhythmia, or severe hypokalemia
- Current smoker
- Neurological disorder (moderate-severe traumatic brain injury, dementia)
- Significant current or past medical or psychiatric history, or use of medications, that, in the opinion of the Investigators, contraindicates their participation, due to influence on outcome measures.
- Patients lacking capacity or unable to consent
- Inability to understand verbal explanations or written information given in English
- Patients currently participating in an active CTIMP trial, or within 4 half-lives of last administration of CTIMP product
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556279
|Imperial College Healthcare NHS Trust|
|London, United Kingdom, W12 0NN|
|Responsible Party:||Imperial College London|
|Other Study ID Numbers:||
|First Posted:||September 21, 2020 Key Record Dates|
|Last Update Posted:||September 21, 2020|
|Last Verified:||September 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||Salt taste thresholds. Taste ratings|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Feeding and Eating Disorders
Adrenal Gland Diseases
Endocrine System Diseases
Mineralocorticoid Receptor Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing