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Einfluss eines Probiotikums auf den Blutdruck von Patienten mit Hypertonie Grad 1 - eine randomisierte klinische Studie (HYPRO)



Short title: HYPRO

Investigated disease: Essentielle Hypertonie Grad 1 (>130/80 mmHg)

Principal Investigator: Dr. med. Michael Boschmann


Clinic, Institute: Experimental and Clinical Research Center (ECRC)

Patient (diseased)
Age: 50 - 80
Gender: All

Status: Participants wanted
Last change: 23.09.2021

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Study Description

Title

Einfluss eines Probiotikums auf den Blutdruck von Patienten mit Hypertonie Grad 1 - eine randomisierte klinische Studie (HYPRO)

Short title

HYPRO

General Short Description

Bluthochdruck ist einer der wichtigsten Risikofaktoren für Herz-Kreislauf-Erkrankungen wie die koronare Herzkrankheit, Herzversagen, Nierenerkrankungen und Schlaganfälle. Trotz einer Vielzahl von Medikamenten liegt nur etwa bei der Hälfte der Behandelten der Blutdruck im empfohlenen Bereich. In einer von uns durchgeführten Pilotstudie ergaben sich Hinweise dafür, dass ein Probiotikum aus 8 lebensfähigen Bakterienstämmen den salzsensitiven Blutdruckanstieg in gesunden Männern verhindern kann. Deshalb untersuchen wir jetzt in einer randomisierten, placebokontrollierten Studie, inwieweit dieses Probiotikum den Blutdruck, das Darm-Mikrobiom, das Immunsystem, den Glucose-Stoffwechsel und die gesundheitsbezogene Lebensqualität von Männern und Frauen mit Bluthochdruck Grad 1 beeinflusst.

Scientific Short Description

High blood pressure is a major risk factor for cardiovascular events, including stroke, heart and kidney failure. Typical anti-hypertensive drugs target vessels, the kidneys or the heart. Here we propose a randomized, placebo-controlled study to test the blood pressure-lowering effect of a probiotic in 110 patients with grade 1 hypertension. In addition, we will investigate glucose variability, fecal bacterial metabolome, peripheral blood effector T cell frequencies (%) and health-related quality of life.

Primary Register Type

ClinicalTrials.gov-No. (NCT)

Primary Register-ID

NCT03906578

Study start

02.09.2019

Study end

01.09.2022

Investigated Disease, Health Issue

ICD-Code
  • I10 - Essentielle (primäre) Hypertonie

Low-to-moderate Risk Grade 1 Hypertension

Inclusion Criteria

Age

50 - 80

Gender

All

Additional Inclusion Criteria
  • Men and postmenopausal women (50-75 years)
  • Treated or untreated grade 1 hypertension (resting office blood pressure >140/90 mmHg)
  • BMI 18.5 - 34.9 kg/m^2

Exclusion Criteria

  • Secondary causes of hypertension
  • Known target organ damage
  • 10 years cardiovascular risk score of >20%
  • Diabetes
  • Established cardiovascular or renal disease
  • Other serious diseases
  • Recent use of antibiotics
  • Specialized diets, e.g. use of probiotics

Characteristics

Studytype

Interventional

Studyphase

N/A

Primary Outcome

1. Nocturnal systolic blood pressure
Measured by 24h ABPM (mmHg)
[Time Frame: After 8 weeks compared to placebo and adjusted to baseline]

Secondary Outcome

2. Nocturnal diastolic blood pressure
3. 24h systolic blood pressure
4. 24h diastolic blood pressure
5. Office systolic blood pressure
6. Office diastolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
7. Reduction of antihypertensive medication
8. Glucose variability after standardized breakfasts
9. Gut microbiome
Change of fecal microbiome composition
10. Metabolomics stool and serum
Change of fecal and serum metabolome
11. Change in immune cell phenotypes
Peripheral blood effector T cell frequencies (%)
12. PROMIS-29 domain pain interference
13. PROMIS-29 domain depression
14. PROMIS-29 domain anxiety
15. PROMIS-29 domain physical function
16. PROMIS-29 domain fatigue
17. PROMIS-29 domain sleep disturbance
18. PROMIS-29 domain ability to participate in social roles and activities

Intervention Groups, Observation Groups

  • Arm 1

    Probiotikum-Gruppe

  • Arm 2

    Placebo-Gruppe

Contact

Contact for Study Participants

Frau Gabriele Rahn

030 450 540 234

leaner(at)charite.de


Contact for Scientific Inquiries

Frau Dr.rer. medic. Anja Mähler

030 450 540 323

anja.maehler(at)charite.de


Downloads

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