Investigating Salt Taste Threshold in Patients Being Investigated for Primary Hyperaldosteronism Before and After Treatment.

NCT04556279 | Withdrawn

• 1 other identifier: 20HH6283
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperaldosteronism; Primary; Hypertension; Salt; Excess; Appetite Disorders

Outcome Measures

Primary Outcomes (2)

• Salt concentration taste threshold

  Concentration of saline at which the salt taste is detected.

  6 months

• Ratings of salt liking and intensity across different salt concentrations

  ratings of liking/wanting and intensity of soup containing differing concentrations of salt.

  6 months

Secondary Outcomes (2)

• Rating of sweet liking and intensity

  6 months

• Rating of sour liking and intensity

  6 months

Study Arms (3)

hyperaldosteronism surgical treatment

Hypertensive patients with primary hypersldosteronism, treated with surgery

Procedure: adrenalectomy

hyperaldosteronism medical treatment

Hypertensive patients with primary hypersldosteronism, treated with aldosterone blockade.

Drug: Aldosterone Antagonist

hypertensive control

Hypertensive patients shown not to have primary hyperaldosteronism

Interventions

adrenalectomy PROCEDURE

Surgical removal of an adrenal gland containing an aldosterone secreting adenoma.

Also known as: aldosterone blockade

hyperaldosteronism surgical treatment

Aldosterone Antagonist DRUG

Medical treatment of primary hyperaldosteronism.

hyperaldosteronism medical treatment

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Institute of Neuroscience and Medicine, Julich, Germany: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension; Feeding and Eating Disorders

Interventions

Adrenalectomy; Mineralocorticoid Receptor Antagonists

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: January 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

GB (1)