- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02591628
Treatment of Hypertension In Adults With ThiaZIDES: Pragmatic Trial Pilot Study (ThiaZIDES)
10. oktober 2017 oppdatert av: HealthPartners Institute
This proposed pilot study will test methods and feasibility for a large pragmatic clinical trial comparing two inexpensive, first-line drugs for treating high blood pressure to determine if one is superior in preventing serious cardiovascular events and death.
It will develop and test novel approaches to conducting trials that will be faster, less expensive, and more realistic by being embedded in a typical practice setting and using advanced health information technology.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
For several decades, U.S. hypertension treatment guidelines have recommended a low-dose diuretic such as hydrochlorothiazide (HCTZ) or chlorthalidone (CTD) as initial monotherapy in a stepped-care approach or as part of an initial two-drug combination.
In numerous large clinical trials, CTD-based regimens have significantly reduced rates of cardiovascular events such as stroke, heart failure, and cardiovascular mortality compared with placebo, usual care, or active comparators.
In contrast, few outcome studies have compared HCTZ-based regimens with other treatments, and they have generally found HCTZ to be less effective than non-thiazide comparators in preventing cardiovascular events.
The two drugs have never been compared directly in a large trial.
Despite the empirical evidence favoring CTD, HCTZ is much more widely used in clinical practice.
The proposed R34 is a pilot study conducted in two large integrated health systems to test methods and feasibility for an eventual pragmatic randomized trial comparing the effectiveness of HCTZ and CTD for preventing cardiovascular events and mortality.
Using a cluster-randomized design, investigators will allocate 40 primary care physicians and their adult hypertensive patients who currently use HCTZ (N=2,000) to either convert HCTZ users to CTD (intervention group) or to continue HCTZ (usual care group).
The pilot study and planned full-scale trial will use existing health care infrastructure and electronic health records to identify eligible study subjects, distribute study medication, and collect operational and outcomes data.
For this pilot study, Aim 1 will document that the intervention is delivered as intended.
Aim 2 will compare safety in intervention and usual care patients.
Aim 3 will refine the pilot study design and identify critical factors for intervention success using a mixed-methods approach.
Aim 4 will refine estimates of sample size.
Finally, Aim 5 will determine the costs of ascertaining outcomes and estimate per-participant costs for the full-scale trial.
The pilot study will produce data that are necessary and sufficient to inform the planning of a full-scale trial comparing CTD and CTZ and will advance the development of methods for pragmatic trials.
Studietype
Intervensjonell
Registrering (Faktiske)
2027
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Minnesota
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Bloomington, Minnesota, Forente stater, 55105
- HealthPartners Institute for Education and Research
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Oregon
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Portland, Oregon, Forente stater, 97227
- Kaiser Permanente Center for Health Research
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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
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adults 18 years and older
- Hypertension diagnosis (ICD-9 401.x)
- Current prescription for hydrochlorothiazide (HCTZ), 12.5-50 mg/day as a single-agent (not part of a fixed-dose combination drug)
- No history of intolerance to chlorthalidone (CTD)
- No known low levels of sodium (<135 mEg/L (milliequivalents per liter)) or potassium (<3.5 mEg/L)
- English speaking
Exclusion Criteria:
- Physician deems patient inappropriate for switching HCTZ to CTD
- Patient refuses the switch prior to intervention
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Intervention
Intervention is HCTZ prescription conversion to chlorthalidone.
Intervention patients are defined as patients of physicians randomized to "intervention."
All these patients will have their current prescription of hydrochlorothiazide (HCTZ) switched to an equipotent dose of Chlorthalidone.
These patients can choose to decline this intervention, and will be followed for 9 months with no other intervention to observe primary and secondary outcomes.
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The intervention is simply a prescription conversion and the main outcome is whether or not patients accept the conversion and treatment with chlorthalidone.
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Ingen inngripen: Usual Care
Usual care patients are defined as patients of physicians randomized to "usual care."
All these patients will keep their current prescription for HCTZ and work with their physician like normal.
These patients will be followed for 9 months with no intervention to compare primary and secondary outcomes to the intervention group.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Conversion to chlorthalidone, number of patients with primary fills
Tidsramme: 3 months
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We will observe pharmacy claims to assess whether intervention patients filled their first prescription for chlorthalidone (primary adherence)
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3 months
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Conversion to chlorthalidone, number of participants with secondary fills
Tidsramme: 9 months
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We will observe pharmacy claims to assess whether intervention patients who filled their first chlorthalidone prescription also filled their subsequent prescription (secondary adherence)
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9 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Blood pressure
Tidsramme: 9 months
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Systolic and diastolic blood pressure measures, as documented in electronic health record
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9 months
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Hypertension drugs
Tidsramme: 9 months
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Use of anti-hypertensive drugs in addition to hydrochlorothiazide or chlorthalidone, as documented in pharmaceutical claims
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9 months
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Electrolyte levels
Tidsramme: 9 months
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Sodium and potassium levels, as documented in electronic health record
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9 months
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Renal function
Tidsramme: 9 months
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Kidney function lab values (including epidermal growth factor receptor (eGFR) and creatinine), as documented in electronic health record
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9 months
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Safety outcomes
Tidsramme: 9 months
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Hypotension with fainting (over-treatment), hypertensive crisis (under-treatment) and other clinical outcomes related to safety of hypertension treatment
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9 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Karen L Margolis, MD, MPH, HealthPartners Institute
- Hovedetterforsker: Stephen P Fortmann, MD, Kaiser Permanente
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. august 2015
Primær fullføring (Faktiske)
1. juli 2017
Studiet fullført (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først innsendt
25. september 2015
Først innsendt som oppfylte QC-kriteriene
28. oktober 2015
Først lagt ut (Anslag)
29. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. oktober 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R34HL119790 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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