Status:
UNKNOWN
Spermidine Anti-Hypertension Study
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
University of Graz
ETH Zurich
Conditions:
Hypertension
Eligibility:
All Genders
19-99 years
Phase:
PHASE3
Brief Summary
The impact of daily spermidine application on arterial blood pressure and other secondary parameters will be evaluated in a double-blind single center 46 patients cross-over study.
Detailed Description
Arterial hypertension is a central risk factor for cardiovascular disease, major cardiovascular events and mortality. Treatment of arterial hypertension necessitates lifestyle modifications, but often...
Eligibility Criteria
Inclusion
- Able to provide signed and dated informed consent form
- Persistant arterial hypertension with systolic blood pressure above 150 mmHg during hospitalisation and the day of randomisation
- Stable anti-hypertensive medication with at least two guideline-recommended anti-hypertensive drugs
Exclusion
- Systolic blood pressure ≥180mmHg on the day of randomisation
- Spermidine intolerance
- Significant renal impairment defined as glomerular filtration rate \< 45ml/min
- Insulin-dependent diabetes mellitus (IDDM)
- Wheat allergy or gluten intolerance
- Life expectancy of less than 12 months
- Participation in another clinical trial
Key Trial Info
Start Date :
February 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04405388
Start Date
February 25 2020
End Date
November 15 2024
Last Update
January 10 2023
Active Locations (1)
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1
Medical University of Graz
Graz, Austria, 8010