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Intravascular Ultrasound Evaluation of Renal Nerves in Different Diseases

22. oktober 2014 oppdatert av: Jing Huang, The Second Affiliated Hospital of Chongqing Medical University

Intravascular Ultrasound Evaluation of the Renal Nerves Remodeling in Different Diseases

Sympathetic hyperactivity is a causal or a promoting factor in many diseases, under these conditions, some morphology changes due to the hyperactivity occur. Renal nerve is an important part in the autonomic nervous system regulation, especially in cardiovascular system, the modulation of the renal nerves used as a therapeutic strategy has been researched across the world. The purpose of this study is to evaluate and quantify the morphology changes in different diseases, make the modulation therapy more selective and effective.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

People eligible for this study will be divided into 4 groups according to the eligibility criteria(Resistant Hypertension Group,Essential Hypertension Group, Chronic Heart Failure Group and Control Group), about 15 objects for each, totally 60 objects are going to be recruited.

Before the intravascular ultrasound examination, ambulatory blood pressure, ECG, plasma catecholamine hormones, renin-angiotension-aldosterone, ect. will be measured. An intravascular ultrasound examination will be taken after all of these have been done.

Studietype

Observasjonsmessig

Registrering (Forventet)

60

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Chongqing
      • Chongqing, Chongqing, Kina, 400010
        • Rekruttering
        • The 2nd affiliated Hospital of Chongqing Medical University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jing Huang, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Hospitalized patients who are going to take a vascular interventional examination.

Beskrivelse

Inclusion Criteria:

  1. Resistant hypertension group

    • blood pressure remains above goal in spite of the concurrent use of three or more anti-hypertensive agents(including a diuretic) at adequate doses.
    • agrees to have the study procedure(s) performed and additional procedures and evaluations

  2. Essential hypertension group

    • systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, or current use of anti-hypertensive medication with a normal blood pressure or mean ambulatory blood pressure during the 24-hour≥130/80 mmHg.
    • not resistant to pharmacotherapy.
    • agrees to have the study procedure(s) performed and additional procedures and evaluations

  3. Chronic heart failure group

    • New York Heart Association class II-III symptoms, or American College of Cardiology(ACC) / American Heart Association(AHA) heart failure classification B-C class of chronic heart failure.
    • currently or prior have the signs of heart failure, such as elevated jugular venous pressure, peripheral edema, pulmonary crepitations, ect.
    • Systolic left ventricular dysfunction as assessed by echocardiogram with left ventricular ejection fraction < 40%.
    • agrees to have the study procedure(s) performed and additional procedures and evaluations

  4. Control group

    • no history of arterial hypertension, heart failure and diabetes
    • going to take a vascular interventional examination during hospitalization
    • agrees to have the study procedure(s) performed and additional procedures and evaluations

All patients have full capacity for civil conduct and agree to sign the Medical Informed Consent.

Exclusion Criteria:

  • hemodynamically or anatomically significant renal artery stenosis.
  • renal artery variation.
  • renal artery diameter < 4 mm, trunk length < 20 mm.
  • secondary hypertension with known causes and pseudo-hypertension.
  • has experienced myocardial infarction, unstable angina pectoris, or cerebrovascular accident within 6 months.
  • has an implantable cardioverter defibrillator (ICD) or pacemaker.
  • requires respiratory support.
  • is pregnant or planning to be pregnant.
  • cardiovascular diseases with sever hemodynamic disorder.
  • type 1 diabetes mellitus.
  • currently enrolled in another investigational drug or device trial.
  • civil disability or limited capacity for civil conduct.
  • other conditions researchers considered unsuitable for enrolled in the trial.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Styre
Essensiell hypertensjon
Kronisk hjertesvikt
Resistant hypertension

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number increase of Renal nerves in patients with sympathetic over-activity diseases
Tidsramme: A duration of the whole research stage, an expected average of 1/2 year
Total number of the renal nerve of each patient(automatic identification by the embedded software in the ultrasound imaging host/counting manually): Number of Nerve Bundles;
A duration of the whole research stage, an expected average of 1/2 year
Area increase of Renal nerves in patients with sympathetic over-activity diseases
Tidsramme: A duration of the whole research stage, an expected average of 1/2 year
Total area of the renal nerve (measured by ultrasound imaging host) of each patient: square millimeter (mm²)=∑= Nerve 1(length*width)+ Nerve 2(length*width)+ ......+ Nerve n(length*width);
A duration of the whole research stage, an expected average of 1/2 year
The increase of the ratio of nerve area/artery wall area in patients with sympathetic over-activity diseases.
Tidsramme: A duration of the whole research stage, an expected average of 1/2 year
  1. Renal artery area of each patient (measured by ultrasound imaging host): Square millimeter (mm²);
  2. Renal arterial wall area (measured by ultrasound imaging host) of each patient: Square millimeter (mm²);
  3. Total area of the renal nerve/Total renal artery area: percentage (%);
  4. Total area of the renal nerve/Total renal arterial wall area: percentage (%);
A duration of the whole research stage, an expected average of 1/2 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants with Serious and Non-Serious Adverse Events Related to The Intervention Procedure
Tidsramme: Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours

Renal arteriography will be carried out post operation to evaluate the possibility of renal artery injuries caused by this procedure, which including:

  1. Emerging renal artery dissection;
  2. Emerging renal artery stenosis, which will not improve by the intravascular injection of nitroglycerin;
  3. Emerging renal artery rupture or perforate;
  4. Contrast-induced nephropathy
  5. Any other complications related to this intervention procedure, such as catheter breakage, infection, hematoma ect.
Participants will be followed for the duration of the operation time, an expected average of 0.5-1 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Etterforskere

  • Hovedetterforsker: Jing Huang, MD, Dept. of Cardiology, the 2nd affiliated hospital of Chongqing Medical University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2014

Primær fullføring (Forventet)

1. februar 2015

Studiet fullført (Forventet)

1. mai 2015

Datoer for studieregistrering

Først innsendt

16. september 2014

Først innsendt som oppfylte QC-kriteriene

17. september 2014

Først lagt ut (Anslag)

18. september 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. oktober 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. oktober 2014

Sist bekreftet

1. oktober 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • US-RNRE
  • NSFC81370440 (Annet stipend/finansieringsnummer: National Natural Science Foundation of China)

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