Hypertension Clinical Trial
— AldoSaltOfficial title:
Investigating Salt Taste Threshold in Patients Being Investigated for Primary Hyperaldosteronism Before and After Treatment.
NCT number | NCT04556279 |
Other study ID # | 20HH6283 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 2021 |
Est. completion date | March 2022 |
Verified date | September 2020 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | March 2022 |
Est. primary completion date | February 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Dr Katrina Ohla, Institute of Neuroscience and Medicine, Julich, Germany |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Salt concentration taste threshold | Concentration of saline at which the salt taste is detected. | 6 months | |
Primary | 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 | Rating of sweet liking and intensity | ratings of liking/wanting and intensity of a sweet taste. | 6 months | |
Secondary | Rating of sour liking and intensity | rating of liking/wanting and intensity of a sour taste. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A | |
Completed |
NCT04303468 -
Intervention With a GABA Supplement in Prediabetics
|
N/A |