N-of-1 Trial to Promote Beta-Blocker Titration in Heart Failure

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

No aplica

Rango de edad

50 años - No especificado

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

50 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

In this study we seek to understand whether N-of-1 trials using a crossover withdrawal/reversal design with 1-5 three-week periods can be used to identify the highest tolerated beta-blocker dose for patients with Heart Failure with Reduced Ejection Fraction (HFrEF). To achieve this objective we will conduct a 2-arm randomized controlled trial of 50 participants, comparing intervention(N-of-1 trials) to enhanced usual care.

For participants randomized to the intervention, we will use collect data via validated patient-reported outcomes and then display this data on a visualization tool. This tool was iteratively developed for N-of-1 trials with patient input - a comparison of how the patient felt on different doses of the same beta-blocker. If well-tolerated and the participant agrees to continue with dose escalation based on review of their data, the participant will take a higher dose for the next 3-week period; and the study team will again collect data on how they feel during this time. This approach of sharing end-of-period data with participants and subsequently escalating the dose (based on the participant's decision) for another 3-week period will continue until the guideline-directed target dose is reached or until the participant feels that their symptoms are limiting dose escalation. The N-of-1 intervention is purposefully structured to allow the participant to participate in 1-5 three-week periods (and as many dose combinations) as they wish until they are confident that they have reached their highest tolerated dose. This adaptive design for N-of-1 trials is intended to be patient-centered and patient-driven.

We will also conduct brief semi-structured interviews with intervention participants.

Participants randomized to enhanced usual care will not have access to patient-reported outcomes or the data visualization tool. Since attention can affect outcomes, we will "enhance usual care" by conducting phone calls at the same frequency as the intervention group.

¿Quién podría participar?

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Inclusion Criteria:

• Adults aged ≥50 years
• Diagnosed with HFrEF (LVEF \<40%)
• Taking below 50% of guideline-based target β-blocker dose (guideline-based target doses: metoprolol succinate 200 mg daily; metoprolol tartrate 200 mg daily; carvedilol 50 mg daily (100 mg daily for participants \>85 kg); bisoprolol 10 mg daily)

Exclusion Criteria:

• Clinical instability, including decompensated HF, hospitalization in the past 30 days, or medication changes/procedures in the prior 14 days at PI discretion
• Estimated life expectancy \<6 months
• Moderate-severe dementia or psychiatric disorder precluding informed consent
• Language barrier precluding informed consent or comprehension of study procedures
• History of noncompliance or inability to complete study procedures
• Enrollment in a clinical trial not approved for co-enrollment
• Any condition that, in the PI's or treating physician's opinion, makes the patient unsuitable for study participation

Tratamiento, grupos y participación

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Asignación

Asignación al azar

Enmascaramiento

Enmascaramiento simple

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (1)

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1 centros

Equipo y fechas

Patrocinador principal

Brigham and Women's Hospital

Inicio del estudio

31 jul 2026 Real

Finalización primaria

5 sept 2027 Estimado

Finalización del estudio

5 oct 2027 Estimado

Primera publicación

24 mar 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.