Spermidine Anti-Hypertension Study

NCT04405388 | Unknown Phase 3

• 1 other identifier: 30-468 ex 17/18
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure in an ambulatory 24h blood pressure measurement

  Patients will get RR recordings in an ambulatory setting

  up to 24 weeks

Secondary Outcomes (5)

• Pulse wave velocity

  up to 24 weeks

• diastolic blood pressure

  up to 24 weeks

• mean blood pressure

  up to 24 weeks

• central blood pressure

  up to 24 weeks

• 6 minute walk test

  up to 24 weeks

Study Arms (2)

Spermidine first

OTHER

First treatment period (8 weeks) will be 4 mg spermidine per day orally. Afterwards 4 weeks of wash-out followed by 8 weeks of placebo treatment.

Drug: Placebo; Drug: Spermidine

Placebo first

OTHER

First treatment period (8 weeks) will be placebo. Afterwards 4 weeks of wash-out followed by 8 weeks of 4 mg spermidine per day orally.

Drug: Placebo; Drug: Spermidine

Interventions

Placebo DRUG

Placebo will be given orally as capsule (same size and weight as Spermidine capula)

Placebo first; Spermidine first

Spermidine DRUG

Spermidine will be given orally as capsule (4mg/day)

Placebo first; Spermidine first

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• University of Graz: collaborator
• ETH Zurich: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University Hospital Tuebingen: collaborator

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

RECRUITING

Related 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, Carmona-Gutierrez D, Buttner S, Pietrocola F, Knittelfelder O, Schrepfer E, Rockenfeller P, Simonini C, Rahn A, Horsch M, Moreth K, Beckers J, Fuchs H, Gailus-Durner V, Neff F, Janik D, Rathkolb B, Rozman J, de Angelis MH, Moustafa T, Haemmerle G, Mayr M, Willeit P, von Frieling-Salewsky M, Pieske B, Scorrano L, Pieber T, Pechlaner R, Willeit J, Sigrist SJ, Linke WA, Muhlfeld C, Sadoshima J, Dengjel J, Kiechl S, Kroemer G, Sedej S, Madeo F. Cardioprotection and lifespan extension by the natural polyamine spermidine. Nat Med. 2016 Dec;22(12):1428-1438. doi: 10.1038/nm.4222. Epub 2016 Nov 14.

  PMID: 27841876 RESULT

• 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;109:181-188. doi: 10.1016/j.cortex.2018.09.014. Epub 2018 Oct 4.

  PMID: 30388439 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Spermidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Putrescine; Biogenic Polyamines; Biogenic Amines; Amines; Organic Chemicals; Polyamines

Study Officials

• Dirk von Lewinski, MD

  MUG

  PRINCIPAL INVESTIGATOR

• Simon Sedej, PhD

  Medical University of Graz

  STUDY DIRECTOR

• Tobias Eisenberg, PhD

  University of Graz

  STUDY DIRECTOR

• Mahmoud Abdellatif, MD, PhD

  Medical University of Graz

  STUDY DIRECTOR

Central Study Contacts

Dirk von Lewinski, MD

CONTACT

+43 316 385; dirk.von-lewinski@medunigraz.at

Markus Wallner, MD

CONTACT

+43 316 385; markus.wallner@medunigraz.at

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: May 28, 2020
• Study Start: February 25, 2020
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)