- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02723643
Potential Associated Factors of Uncontrolled Hypertension
29. marts 2016 opdateret af: Guangdong Provincial People's Hospital
Initial Investigation on Potential Associated Factors of Uncontrolled Hypertension in Outpatient Department: A Prospective Registry Study
The incidence and prevalence of hypertension is increasing while the controlled rate is extremely low in China.
A substantial percentage of participants with uncontrolled hypertension are correctable if potential associated factors are identified and corrected.
Therefore, it is clinically relevant to investigate and identify these potential associated factors of uncontrolled hypertension so as to increase controlled rate and reduce hypertension-associated health and economic burdens in the future.
Investigators plan to conduct a prospective registry study in a single-center to initially investigate the potential associated factors of uncontrolled hypertension in cardiovascular outpatient department.
Furthermore, investigators plan to evaluate the effects of potential associated factors correction on hypertension controlled rate and cardiovascular outcomes.
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
2000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Anping Cai, MD
- Telefonnummer: 8615989267312
- E-mail: caianping1983@hotmail.com
Studiesteder
-
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Guangdong
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Guangzhou, Guangdong, Kina, 510080
- Rekruttering
- Guangdong Cardiovascular Institute,Guangdong General Hospital
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Underforsker:
- Dan Zhou, MD
-
Kontakt:
- Anping Cai, MD
- Telefonnummer: 8615989267312
- E-mail: caianping1983@hotmail.com
-
Kontakt:
- Yingling Zhou, MD
- Telefonnummer: 86-20-83827812-10528
- E-mail: zylgdh123@sina.com
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Ledende efterforsker:
- Yingqing Feng, MD
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Underforsker:
- Qi Zhong, MD
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Underforsker:
- Xida Li, MD
-
Underforsker:
- Xueju Yu, MD
-
Underforsker:
- Huiming Yu, MD
-
Underforsker:
- Yujin Mo, MD
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Underforsker:
- Ying Zhang, MD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Outpatient populations with clinic systolic and/or diastolic blood pressure above 140 and/or 90 mm Hg treating with 3 different classes of anti-hypertensive drugs (not necessarily including diuretic).
Beskrivelse
Inclusion Criteria:
- Clinic systolic and/or diastolic blood pressure above 140 and/or 90 mm Hg treating with 3 different classes of anti-hypertensive drugs (not necessarily including diuretic).
Exclusion Criteria:
- Known secondary hypertension,
- Pregnant women,
- Chronic kidney disease (CKD) 3 or higher,
- Has a history of connective tissue diseases,
- Has a history of any type of cancer,
- Cognitive disorder which could not finish home blood pressure monitoring,
- Has a history of coronary heart disease,ischemic stroke,transient ischemic attack or heart failure.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hypertension controlled rate in participants after potential associated factors are corrected
Tidsramme: Up to 1 month
|
Participants with uncontrolled hypertension (SBP and/or DBP >=140 and/or 90 mm Hg) treating with 3 or more anti-hypertensive drugs (not necessarily including diuretic) in outpatient department will under assessment of hypertension controlled rate 1 month later after initial investigation of potential associated factors.
Based on these findings, investigators will give instructions to participants how to correct those potential associated factors and follow-up participants via telephone or outpatient visit 1 month later to assess whether these corrections could help increase hypertension controlled rate.
Participants will be required to record home blood pressure measurements every day, and average home SBP and DBP will be calculated 1 month later.
If average home SBP/DBP < 135/85 mm Hg then participants will be considered as controlled-case, otherwise uncontrolled case.
|
Up to 1 month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2016
Primær færdiggørelse (Forventet)
1. december 2018
Datoer for studieregistrering
Først indsendt
18. marts 2016
Først indsendt, der opfyldte QC-kriterier
29. marts 2016
Først opslået (Skøn)
30. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. marts 2016
Sidst verificeret
1. marts 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GDREC 2015373H
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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