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PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease (PD-HF)

20. januar 2020 opdateret af: University of Nottingham

PD-HF: A Multi-centre Randomised Controlled Trial of Intermittent Peritoneal Dialysis With Icodextrin-based Solutions on Patients With Severe Heart Failure and Stage 3-4 Chronic Kidney Disease

This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The trial is a multi-centre, prospective, randomised, unblended, controlled trial of intermittent PD with a single daily exchange of icodextrin plus best standard care versus best standard care for the treatment of severe HF and moderate CKD. A second exchange with glucose based solution may be given, should it be required in the investigator's/clinician's opinion. Investigators will randomise 130 participants for 32 weeks with randomisation stratified by participating centre. Participants will be recruited from specialist-led outpatient HF services in 6 NHS trusts and be managed by both cardiologists and nephrologists.

PD catheter insertion will occur according to the participating centre's institutional protocol. Treatment begins 1 week after catheter insertion and consists of a single nightly exchange.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

11

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Derbyshire
      • Derby, Derbyshire, Det Forenede Kongerige, DE22 3DT
        • Derby Teaching Hospitals NHS Foundation Trust

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Severe heart failure (NYHA grade III or IV)
  • Chronic kidney disease stage 3-4
  • Fluid overload resistant to diuretics OR hospital admission for HF in last 6 months
  • Left ventricular ejection fraction ≤40% in last 2 years (moderate/severe)
  • Using optimal HF medication for ≥ 4 weeks including ACE-inhibitor (angiotensin-converting-enzyme inhibitor) OR angiotensin receptor blocker AND aldosterone antagonist AND beta-blocker unless intolerant and without dose change for ≥ 4 weeks
  • Appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated.

Exclusion Criteria:

  • Does not wish to participate
  • Mental incapacity to consent
  • CKD stage 5
  • Normal renal excretory function
  • Haemodynamically significant valvular disease amenable to surgery
  • Cardiac or renal transplantation
  • Considered by the investigator to unsuitable for PD due to previous abdominal surgeries, peritonitis, social circumstances or other reason

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Peritoneal Dialysis Group
These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin.
Procedure: Peritoneal Dialysis
One week after insertion of a PD catheter the intervention group will received a single nightly exchange, using dialysis fluid containing icodextrin; a variable proportion of participants may require a second exchange as directed by the consultant nephrologist as part of routine care. The second exchange would use dialysis fluid containing glucose, not icodextrin. Support and training will be given to each participant by the PD specialist team.
Ingen indgriben: Control Group
These participants will continue to receive standard HF care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The primary end-point is a change of 25 metres walked
Tidsramme: Baseline to week 28
6 Minute Walk Test
Baseline to week 28

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in KCCQ score
Tidsramme: Baseline to week 28
Kansas City Cardiomyopathy Questionnaire
Baseline to week 28
Change in SF36 score
Tidsramme: Baseline to week 28
Short Form 36 questionnaire
Baseline to week 28
Change in Derby Evaluation of Illness online visual analogue scale
Tidsramme: Baseline to week 28
Derby Evaluation of Illness online visual analogue scale
Baseline to week 28
Heart Failure related hospitalisations
Tidsramme: Baseline to week 28
Recording the number of hospitalisations relating to Heart Failure
Baseline to week 28
All cause hospitalisations
Tidsramme: Baseline to week 28
Recording the number of hospitalisations for all causes
Baseline to week 28
Heart failure related mortality
Tidsramme: Baseline to week 28
Recording the number of heart failure deaths
Baseline to week 28
All cause mortality
Tidsramme: Baseline to week 28
Recording the number of all cause deaths
Baseline to week 28

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Episodes of PD associated peritoneal infection
Tidsramme: Baseline to week 28
Recording the numbers of PD associated peritoneal infections
Baseline to week 28
Adverse events spontaneously reported during the study
Tidsramme: Baseline to week 28
Recording and reporting adverse events
Baseline to week 28
Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires
Tidsramme: Baseline to week 28
Comparison between the scores from pen and ink questionnaires and the online visual analogue scale
Baseline to week 28

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Nottingham

Samarbejdspartnere

British Heart Foundation

Efterforskere

  • Ledende efterforsker: Maarten Taal, University of Nottingham

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 (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

18. januar 2016

Først indsendt, der opfyldte QC-kriterier

9. marts 2016

Først opslået (Skøn)

15. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRAS project ID: 158992
  • ref: PG/13/27/29864 (Andet bevillings-/finansieringsnummer: BHF grant)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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 .

Kliniske forsøg med Hjertefejl

Kliniske forsøg med Peritoneal Dialysis

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner