N/A
N=103
Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinical Trial in Navajo Nation
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT05792085 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Percentage That Had Increase in Classes of Guideline Directed Medical Therapy — 66.2; 13.1 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EHR-based GDMT Optimization (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage That Had Increase in Classes of Guideline Directed Medical Therapy |
66.2; 13.1 | — |
| SECONDARY Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy |
79; 22.6 | — |
| SECONDARY Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor |
39.7; 6.3 | — |
| SECONDARY Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors |
37.2; 4.6 | — |
| SECONDARY Rates of Increase/Addition of Aldosterone Receptor Antagonists |
30.6; 0.9 | — |
| SECONDARY Rates of Increase/Addition of Beta-blockers |
3.5; 2.1 | — |
| SECONDARY Addition of or Increase in Dose for ACEi/ARB/ARNI |
46.7; 8.8 | — |
| SECONDARY Addition of or Increase in Dose of Beta-blocker |
17.4; 8 | — |
| SECONDARY Addition of or Increase in Dose of Aldosterone Receptor Antagonists |
38.4; 6.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with heart failure with reduced ejection fraction with last ejection fraction equal to or less than 40%
- Have a primary care physician at Gallup Indian Medical Center or Tohatchi Health Center
- Have been seen in the last 12 months at Gallup Indian Medical Center or Tohatchi Health Center
Exclusion Criteria
- On hospice
- LVAD/translant
- Home inotropes
- No visit in last 12 months at Gallup Indian Medical Center or Tohatchi Health Center
Data sourced from ClinicalTrials.gov (NCT05792085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.