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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 : Not yet recruiting
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
Dr Katrina Ohla, Institute of Neuroscience and Medicine, Julich, Germany
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
hyperaldosteronism surgical treatment
Hypertensive patients with primary hypersldosteronism, treated with surgery
Procedure: adrenalectomy
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 control
Hypertensive patients shown not to have primary hyperaldosteronism



Primary Outcome Measures :
  1. Salt concentration taste threshold [ Time Frame: 6 months ]
    Concentration of saline at which the salt taste is detected.

  2. 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.


Secondary Outcome Measures :
  1. Rating of sweet liking and intensity [ Time Frame: 6 months ]
    ratings of liking/wanting and intensity of a sweet taste.

  2. 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
saliva


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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
Study Population
Hypertensive patients with a raised plasma aldosterone/renin ratio being investigated for primary hyperaldosteronism.
Criteria

Inclusion Criteria:

  • Aged 18-65 years
  • Non-smoker (ex-smokers allowed)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Dr Katrina Ohla, Institute of Neuroscience and Medicine, Julich, Germany
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04556279    
Other Study ID Numbers: 20HH6283
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperaldosteronism
Feeding and Eating Disorders
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Mental Disorders
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents