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Pilot Study of StudyU for N-of-1 Trials in HFrEF Patients (N-of-1 App)

NCT07252310 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-02-19

No results posted yet for this study

Summary

This study will look at whether using a phone app called StudyU can help people with Heart Failure with Reduced Ejection Fraction (HFrEF) reach their recommended dose on their beta blocker.

Conditions

  • Heart Diseases
  • HFrEF - Heart Failure With Reduced Ejection Fraction
  • Heart Failure
  • Heart Failure, Systolic

Interventions

DRUG

beta blockers

Subjects will remain on their current home dose of beta blocker (as prescribed by their treating physician prior to enrollment) during Period 1. In Period 2, the dose will be increased -either doubled or by 50%-to support progression toward the guideline-directed medical therapy (GDMT) target. may choose to continue on the tested dose and conclude the study, or request additional information before selecting their preferred dose. If both the participant and the study clinician agree that further evaluation is needed, a third period will be initiated. In this period, the dose may again be increased-by 50% or doubled relative to the Period 2 dose-if tolerated and agreed upon by the participant. If the new dose is well-tolerated and the participant agrees to continue with dose escalation after reviewing their data, the dose will be increased again-either doubled or increased by 50%-for the next period (Period 3). The study team will continue to collect data.

DEVICE

StudyU Application

StudyU is a novel mobile app developed for the design of and conduct of N-of-1 trials. StudyU consists of the StudyU Designer, a web platform and mobile app, accessible through the website https://designer.studyu.health; the StudyU App for smartphones, which can be downloaded from Apple and Google app stores, and the secure backend where data is stored. All components of StudyU were developed by Dr. Stefan Konigorski and his colleagues at Hasso-Plattner Institute (HPI) for Digital Engineering at the University of Potsdam. The StudyU platform allows investigators to easily operationalize their study processes in the StudyU designer. In the StudyU designer, investigators indicate at which frequency subjects will complete assessments. For this pilot trial, a WCM-specific instance of StudyU will be developed and hosted on the secure WCM server. Only the WCM study team will have access to the subject data from the StudyU App.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Parag Goyal, MD, MSc · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2027-02-28
Completion
2027-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07252310 on ClinicalTrials.gov