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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease (STIMULUS-CKD)

18. Mai 2026 aktualisiert von: Institut National de la Santé Et de la Recherche Médicale, France
This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

165

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • Common Inclusion Criteria:

    • Adults aged over 18 years, of both sexes
    • Patients eligible for or affiliated with a social security scheme
    • Patients who have provided written informed consent to participate in the study

Common Exclusion Criteria:

  • Inability to give informed consent
  • Persons under legal protection (guardianship, trusteeship, or court protection)
  • Language barrier or psychological refusal to read the information
  • Medical conditions with a life expectancy < 1 year according to clinical judgment
  • Ongoing participation restriction due to another clinical research study
  • Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)
  • Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block

Exclusion Criteria:

  • Hypertension Group

    • Inclusion: Prior diagnosis of arterial hypertension
    • Stable cardiovascular treatment in the previous 1 month

    • Exclusion:

      • CKD with GFR <60 mL/min
      • ACR > 30 mg/mmol
      • Type 2 diabetes Type 2 Diabetes Group
    • Inclusion:
    • Prior diagnosis of type 2 diabetes
    • Stable cardiovascular treatment in the previous 1 month

    • Exclusion:

      • CKD with GFR < 60 mL/min
      • ACR > 30 mg/mmol Moderate CKD Group
    • Inclusion:
    • Moderate CKD (eGFR between 30 and 60 mL/min) (CKD-EPI)
    • Patients scheduled for arterial stiffness assessment as part of routine care
    • Stable cardiovascular treatment in the previous 1 month
    • Exclusion:
    • No specific exclusion criteria beyond common exclusions Severe CKD Group

    • Inclusion:

      • Severe CKD (GFR < 30 mL/min for ≥ 2 months)
      • Patients scheduled for arterial stiffness assessment as part of routine care
      • Stable cardiovascular treatment the previous 1 month
    • Exclusion: No specific exclusion criteria beyond common exclusions20 / 48 C25-07_Protocole_ V1.0_01.12.2025 Healthy Volunteers Group
    • Inclusion: No documented chronic disease

    • Exclusion:

      • Moderate or severe CKD (GFR < 60 mL/min) (CKD-EPI)
      • Hypertension
      • Type 2 diabetes
      • Stable cardiovascular treatment in the previous 1 month

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Healthy Volunteers
Adults without known hypertension, type 2 diabetes, or chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Gerät: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Gerät: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.
Experimental: Hypertension Without Chronic Kidney Disease
Adults with hypertension and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Gerät: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Gerät: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.
Experimental: Type 2 Diabetes Mellitus Without Chronic Kidney Disease
Adults with type 2 diabetes mellitus and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Gerät: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Gerät: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.
Experimental: Moderate Chronic Kidney Disease
Adults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Gerät: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Gerät: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.
Experimental: Severe Chronic Kidney Disease
Adults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
Gerät: HEMI device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
Gerät: SPG-NINOX device
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
HEMI-derived small vessel pressure at baseline
Zeitfenster: Baseline (single study visit, approximately 60 minutes)
Small vessel pressure derived from the HEMI non-invasive investigational device under standardized resting conditions at baseline. The primary analysis compares values across the five study groups.
Baseline (single study visit, approximately 60 minutes)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Mitarbeiter

University of Turku
Imec

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juni 2026

Primärer Abschluss (Geschätzt)

15. März 2028

Studienabschluss (Geschätzt)

15. September 2028

Studienanmeldedaten

Zuerst eingereicht

18. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • C25-07

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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