PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease (PD-HF)
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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Derbyshire
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Derby、Derbyshire、イギリス、DE22 3DT
- Derby Teaching Hospitals NHS Foundation Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Peritoneal Dialysis Group
These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin.
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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.
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介入なし:Control Group
These participants will continue to receive standard HF care.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The primary end-point is a change of 25 metres walked
時間枠:Baseline to week 28
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6 Minute Walk Test
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Baseline to week 28
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in KCCQ score
時間枠:Baseline to week 28
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Kansas City Cardiomyopathy Questionnaire
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Baseline to week 28
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Change in SF36 score
時間枠:Baseline to week 28
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Short Form 36 questionnaire
|
Baseline to week 28
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Change in Derby Evaluation of Illness online visual analogue scale
時間枠:Baseline to week 28
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Derby Evaluation of Illness online visual analogue scale
|
Baseline to week 28
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Heart Failure related hospitalisations
時間枠:Baseline to week 28
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Recording the number of hospitalisations relating to Heart Failure
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Baseline to week 28
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All cause hospitalisations
時間枠:Baseline to week 28
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Recording the number of hospitalisations for all causes
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Baseline to week 28
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Heart failure related mortality
時間枠:Baseline to week 28
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Recording the number of heart failure deaths
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Baseline to week 28
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All cause mortality
時間枠:Baseline to week 28
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Recording the number of all cause deaths
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Baseline to week 28
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Episodes of PD associated peritoneal infection
時間枠:Baseline to week 28
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Recording the numbers of PD associated peritoneal infections
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Baseline to week 28
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Adverse events spontaneously reported during the study
時間枠:Baseline to week 28
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Recording and reporting adverse events
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Baseline to week 28
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Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires
時間枠:Baseline to week 28
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Comparison between the scores from pen and ink questionnaires and the online visual analogue scale
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Baseline to week 28
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Maarten Taal、University of Nottingham
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
心不全の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)