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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Kashvi Gupta, MD, MPH
- Telefonnummer: 734-546-4545
- E-post: Kashvi.Gupta@ucsf.edu
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna, 94110
- Har inte rekryterat ännu
- Zuckerberg San Francisco General Hospital
-
Kontakt:
- Kashvi Gupta, MD, MPH
- Telefonnummer: 734-546-4545
- E-post: kashvi.gupta@ucsf.edu
-
San Francisco, California, Förenta staterna, 94014
- Rekrytering
- Satellite Healthcare - Daly City
-
Kontakt:
- Kashvi Gupta, MD, MPH
- Telefonnummer: 734-546-4545
- E-post: kashvi.gupta@ucsf.edu
-
San Francisco, California, Förenta staterna, 94118
- Rekrytering
- Satellite Healthcare - San Francisco Geary
-
Kontakt:
- Kashvi Gupta, MD, MPH
- Telefonnummer: 734-546-4545
- E-post: kashvi.gupta@ucsf.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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. |
|
Övrig: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of enrolling participants
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Retention of study participants
Tidsram: 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
Tidsram: 4.5 months
|
4.5 months
|
|
|
Patient adherence to home BP measurements and recommended adjustments in dialysis prescription and medications
Tidsram: 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
Tidsram: 4.5 months
|
4.5 months
|
|
|
Change in residual kidney function under two different SBP targets
Tidsram: 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
Tidsram: 4.5 months
|
4.5 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Qualitative themes identified from the end-of-study structured participant interviews
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Chi-yuan Hsu, MD, MS, University of California, San Francisco
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens
- Njurinsufficiens, kronisk
- Patologiska tillstånd, tecken och symtom
- Hypertoni
- Njursvikt, kronisk
Andra studie-ID-nummer
- STUDY00000009
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .