CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 103 enrolled
Drug / intervention
EHR-based GDMT Optimizationbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05792085
NCT05792085N/ACompleted

Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinic Trial of Telephone-Based GDMT Optimization in Navajo Nation

University of Pennsylvania·interventional·Posted Mar 30, 2023·Updated Jan 30, 2025

In Brief

A clinical study evaluating EHR-based GDMT Optimization for Heart Failure. Completed, enrolled 103 participants across 2 sites.

Detailed Summary

Heart failure causes significant morbidity and mortality, particularly in Navajo Nation. There are well-established evidence of improved mortality and lower heart failure hospitalizations with certain pharmacotherapies for heart failure with reduced ejection fraction (HFrEF). However, these medications are underutilized nationally, including in the Indian Health Service which is one important driver of poor heart failure outcomes. Therefore, as part of an EHR-based pragmatic clinic trial, we are implementing and testing a model that identifies American Indian HFrEF patients receiving care at one large Indian Health Service Site who meet clinical criteria for, but are not on appropriate therapy, and implements a model in patients are initiated and titrated on appropriate therapy over the phone with remote tele monitoring using home blood pressure cuff. We will evaluate the impact of this model to improve uptake of GDMT among HFrEF patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 30, 2023
Enrollment StartFeb 1, 2023
Primary CompletionAug 1, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.3 years ago

Interventions

EHR-based GDMT Optimizationbehavioral

Patients will be prescribed appropriate GDMT for HFrEF if they meet clinical criteria by the study team, appropriate lab work and follow up testing will be sent and followed up by the team. All recommendations and plans will be copied to primary care providers who can opt out if disagree, but also to improve telementoring to build clinical comfort.