Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial (GOAL-BP)
The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study.
Researchers will compare two goals for the top blood pressure number (systolic blood pressure): below 120 mmHg versus below 140 mmHg.This pilot study will help plan a larger trial in the future.
Participants will:
- Be assigned by chance to one of the two blood pressure goals.
- Have their blood pressure measured at clinic visits about every two weeks.
- Work with their kidney doctor on recommended changes to fluid management, peritoneal dialysis treatment, or blood pressure medicines to reach their assigned goal.
- Be part of the study for about four and a half months.
調査の概要
状態
詳細な説明
Peritoneal dialysis (PD) use among patients with end-stage kidney disease (ESKD) has increased substantially over the last decade. Yet there are no randomized clinical trials evaluating blood pressure (BP) targets in patients receiving PD.
GOAL-BP is a pilot study that will evaluate the feasibility of enrolling patients receiving PD to two systolic blood pressure targets (SBP): <120mmHg vs. <140 mmHg.
BP management will be guided by standardized clinic measurements. The study team will make recommendations to the treating nephrologist to achieve the goal SBP using a stepwise approach that addresses volume status before recommending changes to antihypertensive medications. The treating nephrologist will make the final decision about any changes to clinical care.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kashvi Gupta, MD, MPH
- 電話番号：734-546-4545
- メール：Kashvi.Gupta@ucsf.edu
研究場所
-
-
California
-
San Francisco、California、アメリカ、94110
- まだ募集していません
- Zuckerberg San Francisco General Hospital
-
コンタクト：
- Kashvi Gupta, MD, MPH
- 電話番号：734-546-4545
- メール：kashvi.gupta@ucsf.edu
-
San Francisco、California、アメリカ、94014
- 募集
- Satellite Healthcare - Daly City
-
コンタクト：
- Kashvi Gupta, MD, MPH
- 電話番号：734-546-4545
- メール：kashvi.gupta@ucsf.edu
-
San Francisco、California、アメリカ、94118
- 募集
- Satellite Healthcare - San Francisco Geary
-
コンタクト：
- Kashvi Gupta, MD, MPH
- 電話番号：734-546-4545
- メール：kashvi.gupta@ucsf.edu
-
-
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:
- Age ≥ 18 years.
- Undergoing regular PD for treatment of ESKD.
- On PD for ≥ 4 months. (We do not plan to enroll patients within the first 3 months of PD initiation because there can be large fluctuations in volume status and BP readings before patient coming into more of a steady state. We then require participants to have at least 1 month of BP data to allow calculation of an average pre-enrollment BP for screening for study entry.)
- Diagnosis of HTN defined as being on antihypertensive medications or having routine clinic SBP ≥ 140 mmHg averaged over prior one month to screening.
- Able to measure brachial BP.
Exclusion Criteria:
- Planned transplant or HD transition < 4.5 months (the duration of study).
- Estimated life expectancy < 4.5 months (also determined by asking the treating nephrologist).
- Participation in another clinical trial that may affect BP management.
- Pregnancy, anticipated pregnancy, or breastfeeding as this will limit the use of certain antihypertension medications in the study and pose additional risks to the patient and many pregnant patients are transitioned over to hemodialysis.
- Incarceration or institutionalized living which may prohibit measurement of home BP.
- Presence of a condition or abnormality that, in the opinion of the study team or treating nephrologist, would compromise the safety of the patient or the quality of the data.
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 |
|---|---|
|
他の：Intervention
Target systolic blood pressure <120 mmHg |
The target SBP <120 mmHg will be operationalized as SBP 100-119 mmHg in the intervention arm. For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics. Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain SBP <120 mmHg in the interventional arm. If SBP were <100 mmHg at one visit or <105 mmHg at two consecutive visits, BP medications will be reduced to keep SBP in the range of 100 to 119 mmHg, to avoid hypotensive episodes. |
|
他の：Control
Target systolic blood pressure <140 mmHg |
The target SBP <140 mmHg will be operationalized as SBP 130-139 mmHg. For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics. Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain <140 mmHg in the control arm. If SBP were <130 mmHg at one visit or <135 mmHg at two consecutive visits, BP medications will be tapered/discontinued to keep SBP in the range of 130 to 139 mmHg. |
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 |
|---|---|---|
|
Feasibility of enrolling participants
時間枠：4.5 months
|
The primary feasibility endpoint is the screen-to-enrollment ratio, calculated as the number of participants randomized divided by the number of potentially eligible individuals screened during the recruitment period. Physician refusal and patient refusal rates will also be reported. |
4.5 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Retention of study participants
時間枠：4.5 months
|
The duration a study participant will be in the study, from the baseline visit. |
4.5 months
|
|
Physician adherence to protocol recommendations for achieving target SBP
時間枠：4.5 months
|
4.5 months
|
|
|
Patient adherence to home BP measurements and recommended adjustments in dialysis prescription and medications
時間枠：4.5 months
|
Adherence will be assessed by the number of times a patient follows the recommendations across BP measurements, changes in dialysis prescription, and medications. |
4.5 months
|
|
SBP achieved in each arm
時間枠：4.5 months
|
4.5 months
|
|
|
Change in residual kidney function under two different SBP targets
時間枠：4.5 months
|
Residual kidney function is assessed by 24-hour urine collection as per the dialysis unit protocol and indication. These will be assessed to determine any changes. |
4.5 months
|
|
Safety of targeting SBP <120 mmHg vs. <140 mmHg
時間枠：4.5 months
|
4.5 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Qualitative themes identified from the end-of-study structured participant interviews
時間枠：4.5 months
|
Structured participant interviews will be administered by the study team to the patient to collect qualitative feedback, which will be organized into themes. |
4.5 months
|
協力者と研究者
捜査官
- 主任研究者：Chi-yuan Hsu, MD, MS、University of California, San Francisco
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00000009
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個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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