Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation
Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation: a Randomised, Prospective and Controlled Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This randomised, controlled and prospective study aims mainly to investigate the effects of two approaches to control blood pressure in hypertensive hemodialysis patients; using antihypertensive drugs versus persistent strict volume control without using antihypertensive drugs on cardiac structure (mainly left ventricular hypertrophy)and inflammation.
We hypothesize that better blood pressure control and regression of left ventricular mass may be reached by a policy of strict volume control consisting of strict dietary salt restriction and persistent ultrafiltration.
258 Hypertensive hemodialysis patients (BP>130/80 mmHg and/or being on antihypertensive medication) will be randomized to two arms:
Group 1: Antihypertensive medicine will be stopped and strict volume control policy will be applied.
Group 2: Antihypertensive medicine will be continued. Target BP will be 130/80 mmHg in both groups.
The patients will be evaluated at 12 months for primary outcomes. Primary end-points are significant changes in left ventricular hypertrophy and left ventricular mass and significant change in left ventricular end-diastolic volume.
Secondary end-points are changes in post-dialysis weight, changes in hematocrit, albumin, BNP and hsCRP levels.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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-
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Adana, Tyrkia, 01100
- Adana Numune Research and Education Hospital
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Izmir
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Bornova, Izmir, Tyrkia, 35100
- Ege University School of Medicine Division of Nephrology
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- aged between 18-70 years old
- on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
- willingness to participate in the study with a written informed consent.
Exclusion Criteria:
- to be scheduled for living donor renal transplantation
- to have serious life-limiting co-morbid situations; namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease; pregnancy or lactating
Studieplan
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: strict volume control policy
strict volume control policy: Antihypertensive medicine will be stopped and strict volume control policy will be applied.
|
strict volume control by UF and dietary salt restriction
|
|
Annen: antihypertensive drugs administration
antihypertensive drugs administration: Antihypertensive medicine will be continued.
Target BP will be 130/80 mmHg in both groups.
|
continue antihypertensive medications
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
regression of left ventricular hypertrophy
Tidsramme: one year
|
one year
|
|
regression of left ventricular mass
Tidsramme: one year
|
one year
|
|
change in left ventricular end-diastolic volume
Tidsramme: one year
|
one year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
change in post-dialysis weight, changes in hematocrit, albumin, changes in BNP and hsCRP levels
Tidsramme: one year
|
one year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Ercan Ok, M.D, Ege University School of Medicine Nephrology Department
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Ege1336
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