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Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinical Trial in Navajo Nation
NA trial testing EHR-based GDMT Optimization in Heart Failure in 103 participants. Completed in 1 August 2023.
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 103 |
| Start date | 1 February 2023 |
| Primary completion | 1 August 2023 |
| Estimated completion | 1 August 2023 |
| Sites | 2 locations across United States |
University of Pennsylvania
18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
% of Patients that had Increase in the number of classes of Guideline Directed Medical Therapy (Beta-blocker, ACEi/Angiotensin receptor blockers, Angiotensin Receptor-Neprilysin Inhibitor, Aldosterone receptor antagonists, SGLT2i)
| Group | Value | 95% CI |
|---|---|---|
| Telehealth Model | 66.2 | |
| Control | 13.1 |
Proportion of patients that had an increase in the number of classes or dose of Guideline Directed Medical Therapy (Beta-blocker, Angiotensin-converting enzyme inhibitors/Angiotensin receptor blockers, Angiotensin Receptor-Neprilysin Inhibitor, Aldosterone receptor antagonists, Sodium-glucose co-transporter 2 inhibitors)
| Group | Value | 95% CI |
|---|---|---|
| Telehealth Model | 79 | |
| Control | 22.6 |
Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan)
| Group | Value | 95% CI |
|---|---|---|
| Telehealth Model | 39.7 | |
| Control | 6.3 |
Rates of Rx for Sodium-glucose co-transporter 2 inhibitors
| Group | Value | 95% CI |
|---|---|---|
| Telehealth Model | 37.2 | |
| Control | 4.6 |
Rates of Rx for Aldosterone receptor antagonists
| Group | Value | 95% CI |
|---|---|---|
| Telehealth Model | 30.6 | |
| Control | 0.9 |
Rates of Rx for Beta-blockers
| Group | Value | 95% CI |
|---|---|---|
| Telehealth Model | 3.5 | |
| Control | 2.1 |
Increase in Dose for ACEi/ARB/ARNI
| Group | Value | 95% CI |
|---|---|---|
| Telehealth Model | 46.7 | |
| Control | 8.8 |
Addition of or Increase in Dose for Beta-blocker
| Group | Value | 95% CI |
|---|---|---|
| Telehealth Model | 17.4 | |
| Control | 8 |
Dose increase or addition of Aldosterone receptor antagonists
| Group | Value | 95% CI |
|---|---|---|
| Telehealth Model | 38.4 | |
| Control | 6.5 |
Baseline and follow up comfort prescribing therapy: Through survey we will assess at baseline and on follow-up how comfortable (from 1-5) providers feel with prescribing each of the following medications: Beta-blocker, Aldosterone receptor antagonist, Angiotensin-converting enzyme inhibitors, Angiotensin Receptor-Neprilysin Inhibitors, Sodium-glucose co-transporter 2 inhibitors. This measure is a score on a scale from 1-5, with 1 indicating low comfort level and 5 indicating high comfort level.
| Group | Value | 95% CI |
|---|---|---|
| Baseline | 1.86 | ± 0.86 |
| 6 Months | 4.36 | ± 0.63 |
Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
|---|---|---|---|---|---|---|
| Any other minor adverse event | Cardiac disorders | — | — | — | — | — |
Data from ClinicalTrials.gov NCT05792085 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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