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Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial (GOAL-BP)

3 de noviembre de 2026 actualizado por: University of California, San Francisco

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

10

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Kashvi Gupta, MD, MPH
  • Número de teléfono: 734-546-4545
  • Correo electrónico: Kashvi.Gupta@ucsf.edu

Ubicaciones de estudio

  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94110
        • Aún no reclutando
        • Zuckerberg San Francisco General Hospital
        • Contacto:
      • San Francisco, California, Estados Unidos, 94014
        • Reclutamiento
        • Satellite Healthcare - Daly City
        • Contacto:
      • San Francisco, California, Estados Unidos, 94118
        • Reclutamiento
        • Satellite Healthcare - San Francisco Geary
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Intervention

Target systolic blood pressure <120 mmHg
Otro: 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.
Otro: Control

Target systolic blood pressure <140 mmHg
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility of enrolling participants
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Retention of study participants
Periodo de tiempo: 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
Periodo de tiempo: 4.5 months
4.5 months
Patient adherence to home BP measurements and recommended adjustments in dialysis prescription and medications
Periodo de tiempo: 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
Periodo de tiempo: 4.5 months
4.5 months
Change in residual kidney function under two different SBP targets
Periodo de tiempo: 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
Periodo de tiempo: 4.5 months
4.5 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Qualitative themes identified from the end-of-study structured participant interviews
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of California, San Francisco

Investigadores

  • Investigador principal: Chi-yuan Hsu, MD, MS, University of California, San Francisco

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

30 de octubre de 2026

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

28 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de octubre de 2026

Publicado por primera vez (Actual)

2 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00000009

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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