Spermidine Anti-Hypertension Study

Hypertension Clinical Trial

— SMARTEST  

Official title:

Spermidine Anti-Hypertension Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405388
• Other study ID #: 30-468 ex 17/18
• Status: Recruiting
• Phase: Phase 3
• Start date: February 25, 2020
• Est. completion date: November 15, 2024

Study information

• Verified date: January 2023
• Source: Medical University of Graz
• Contact: Dirk von Lewinski, MD
• Phone: +43 316 385
• Email: dirk.von-lewinski[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 also requires medical intervention. In most cases, a combination of two or more anti-hypertensive drugs is recommended and necessary for reaching the target blood pressure levels.

Hypotheses / research questions/objectives Spermidine potentiates the blood pressure lowering effect of standard anti-hypertensive medications, particularly when a combination of at least two first-line drugs (as recommended by the European Society of Cardiology guidelines) has not resulted in sufficient and adequate blood pressure control.

Approach/methods Spermidine Anti-Hypertension Study (SMARTEST) is a prospective, randomized and double-blind placebo-controlled single-centre trial with a balanced 2x2 crossover design, where 46 medically pre-treated hypertensive patients will be subsequently treated with spermidine and placebo (each for eight weeks) in two arms of opposite treatment sequence. A washout period of four weeks will separate the two intervention periods in both arms.

Patients will undergo physical examination, ECG (electrocardiogram), echocardiography, and blood draws at four time points coinciding with the baseline and termination of each treatment at: 0, 8, 12, and 20 weeks of/after recruitment at the Department of Cardiology, Medical University of Graz. In addition, 24-hour ambulatory blood pressure (24-h BP) monitoring (BPM; Mobil-O-Graph®) and on-site blood pressure will be obtained (the device will be sent back to the hospital the following day) at these time points. A 6-minute walk test (6MWT) will be performed at every visit.

Spermidine will be administered orally as an approved dietary supplement (spermidine-rich wheat germ extract) at a dose of 4 mg spermidine per day for eight weeks. The primary outcome will be arterial systolic blood pressure at 24h BPM. Further secondary outcomes/safety outcomes will be:

24-h BP: analysis of systolic, diastolic and mean arterial blood pressures and pulse wave analysis; on site ambulatory blood pressure; 6 minute walk test distance (difference in meters); laboratory analysis; ECG - standard parameters; Echocardiography: standard parameters as well as strain analysis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Placebo
Placebo will be given orally as capsule (same size and weight as Spermidine capula)
• Spermidine
Spermidine will be given orally as capsule (4mg/day)

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (5)

Lead Sponsor	Collaborator
Medical University of Graz	ETH Zurich, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital Tuebingen, University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Eisenberg T, Abdellatif M, Schroeder S, Primessnig U, Stekovic S, Pendl T, Harger A, Schipke J, Zimmermann A, Schmidt A, Tong M, Ruckenstuhl C, Dammbrueck C, Gross AS, Herbst V, Magnes C, Trausinger G, Narath S, Meinitzer A, Hu Z, Kirsch A, Eller K, Carmo — View Citation

Wirth M, Benson G, Schwarz C, Kobe T, Grittner U, Schmitz D, Sigrist SJ, Bohlken J, Stekovic S, Madeo F, Floel A. The effect of spermidine on memory performance in older adults at risk for dementia: A randomized controlled trial. Cortex. 2018 Dec;109:181- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure in an ambulatory 24h blood pressure measurement	Patients will get RR recordings in an ambulatory setting	up to 24 weeks
Secondary	Pulse wave velocity	recorded with the Mobil-O-Graph® PWA, I.E.M. GmbH, Stolberg, Germany	up to 24 weeks
Secondary	diastolic blood pressure	recorded with the Mobil-O-Graph® PWA, I.E.M. GmbH, Stolberg, Germany	up to 24 weeks
Secondary	mean blood pressure	recorded with the Mobil-O-Graph® PWA, I.E.M. GmbH, Stolberg, Germany	up to 24 weeks
Secondary	central blood pressure	recorded with the Mobil-O-Graph® PWA, I.E.M. GmbH, Stolberg, Germany	up to 24 weeks
Secondary	6 minute walk test	tested at every visit	up to 24 weeks