high blood pressure, hypertension high blood pressure
Conditions
Interventions
Patients will be randomly assigned to the food supplement Endocalyx or placebo
in addition to their current medication for 12 weeks. Patients in the Endocalyx
and placebo arm will receive 4 capsules
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Treatment resistant hypertension or hard-to-control hypertension. Treatment resistant hypertension defined as an uncontrolled office BP (=140/90 mmHg).is on a regimen of =3 adequately dosed antihypertensive agents of different classes, including a diuretic, at maximum tolerated dose based on investigator judgment.Hard-to-control hypertension defined as an uncontrolled office BP (=140/90 mmHg).is on a regimen of 2 adequately dosed antihypertensive agents of different classes at maximum tolerated dose based on investigator judgment.Stable diuretic and antihypertensive treatment for the previous 3 weeks.Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
Exclusion criteria
Exclusion criteria: 1. Age 5 mg/day 12. Use of any other investigational drug. 13. Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year. 14. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 15. Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx. 15. Bekende overgevoeligheid voor zeewier, maïs, artisjok, druif, meloen of voor één van de hulpstoffen van Endocalyx. 16. Known hypersensitivity or allergies for milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. 17. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption. 18. (Only applicable to participants interested in the additional measurements using the 7T sodium MRI ) Known contra-indication for MRI scans. Metallic foreign body, certain drug pumps, hydrocephalus pump, external prosthesis (e.g. artificial limb), intrauterine device, vascular clips/stents/pumps, cardiac implantable devices, neuro-stimulator, artificial valves, implanted lenses, prosthesis or cochlear implants, bones screws, plates, claustrophobia and orthopnea might be considered a contra-indication for MRI. In all of these cases, the MR operator will search MRISafety.com to see if the person can be scanned safely. If it is not clear whether the subject can be safely scanned with the 7T MRI, a colleague from Spinoza will be contacted to discuss whether this patient can be scanned safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour systolic blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be used to investigate the mechanism by which Endocalyx may improve hypertension and to assess the safety in patients with treatment resistant hypertension: - 24-hour blood pressure parameters: daytime blood pressure, night-time blood pressure, dipping status - Office blood pressure. - Percentage of patients that needed additional antihypertensive drugs during the study - Percentage of patients that required lowering of antihypertensive drugs during the study - Percentage of patients with an office blood pressure | — |
Countries
Netherlands
Contacts
Public ContactR.H.G. Olde Engberink
Amsterdam UMC
Outcome results
None listed