Heart FailureHozhoNCT05792085
Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinical Trial in Navajo Nation
A study testing EHR-based GDMT Optimization in people with Heart Failure, run by University of Pennsylvania at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- EHR-based GDMT Optimization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- On hospice
- LVAD/translant
- Home inotropes
- No visit in last 12 months at Gallup Indian Medical Center or Tohatchi Health Center
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gallup Indian Medical Center
Gallup, New Mexico, 87301
Tohatchi Health Center
Tohatchi, New Mexico, 87325
About this study
Official title: Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinic Trial of Telephone-Based GDMT Optimization in Navajo Nation
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.
- Conditions
- Heart Failure
- Being tested
- EHR-based GDMT Optimization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR-based GDMT OptimizationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Model | Active comparator | Patient enrolled in the GDMT Telehealth HF improvement program in which hone BP cuff is provided and medication is initiated and titrated over the phone Receives: Behavioral: EHR-based GDMT Optimization |
| Control | No intervention | Usual care, control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy
% 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)
Measured: 30 days
Secondary outcomes (8)
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy
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)
Measured: 30 days
Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor
Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan)
Measured: 30 days
Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors
Rates of Rx for Sodium-glucose co-transporter 2 inhibitors
Measured: 30 days
Rates of Increase/Addition of Aldosterone Receptor Antagonists
Rates of Rx for Aldosterone receptor antagonists
Measured: 30 days
Rates of Increase/Addition of Beta-blockers
Rates of Rx for Beta-blockers
Measured: 30 days
Addition of or Increase in Dose for ACEi/ARB/ARNI
Increase in Dose for ACEi/ARB/ARNI
Measured: 30 days
Addition of or Increase in Dose of Beta-blocker
Addition of or Increase in Dose for Beta-blocker
Measured: 30 days
Addition of or Increase in Dose of Aldosterone Receptor Antagonists
Dose increase or addition of Aldosterone receptor antagonists
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Health Service (IHS)
- Responsible party
- Sponsor
- Investigators
- Maricruz Merino, MD, Study director, Indian Health Service (IHS)Lauren Eberly, MD, MPH, Principal investigator, Indian Health Service, Upenn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792085
- Sponsor's protocol ID
- 02141989
- Acronym
- Hozho
- Status last verified
- Dec 2024
- First submitted
- 26 Jan 2023
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data is protected by the Navajo Nation Human Research Board
Publications
Eberly LA, Tennison A, Mays D, Hsu CY, Yang CT, Benally E, Beyuka H, Feliciano B, Norman CJ, Brueckner MY, Bowannie C, Schwartz DR, Lindsey E, Friedman S, Ketner E, Detsoi-Smiley P, Shyr Y, Shin S, Merino M. Telephone-Based Guideline-Directed Medical Therapy Optimization in Navajo Nation: The Hozho Randomized Clinical Trial. JAMA Intern Med. 2024 Jun 1;184(6):681-690. doi: 10.1001/jamainternmed.2024.1523.
PubMed 38583185
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinic Trial of Telephone-Based GDMT Optimization in Navajo Nation
- ClinicalTrials.gov ID
- NCT05792085
- Acronym / sponsor ID
- Hozho / 02141989
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Indian Health Service (IHS)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped Wedge Design
| Arm | Type | Receives |
|---|---|---|
| Telehealth Model | Active comparator | Behavioral: EHR-based GDMT OptimizationPatient enrolled in the GDMT Telehealth HF improvement program in which hone BP cuff is provided and medication is initiated and titrated over the phone |
| Control | No intervention | –Usual care, control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- On hospice
- LVAD/translant
- Home inotropes
- No visit in last 12 months at Gallup Indian Medical Center or Tohatchi Health Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHR-based GDMT OptimizationPatients 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. | Behavioural | Telehealth Model |
Primary outcome
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy
Time frame: 30 days
% 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)
8 secondary outcomes
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy
Time frame: 30 days
Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor
Time frame: 30 days
Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors
Time frame: 30 days
Rates of Increase/Addition of Aldosterone Receptor Antagonists
Time frame: 30 days
Rates of Increase/Addition of Beta-blockers
Time frame: 30 days
Addition of or Increase in Dose for ACEi/ARB/ARNI
Time frame: 30 days
Addition of or Increase in Dose of Beta-blocker
Time frame: 30 days
Addition of or Increase in Dose of Aldosterone Receptor Antagonists
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38583185Eberly LA, Tennison A, Mays D, Hsu CY, Yang CT, Benally E, Beyuka H, Feliciano B, Norman CJ, Brueckner MY, Bowannie C, Schwartz DR, Lindsey E, Friedman S, Ketner E, Detsoi-Smiley P, Shyr Y, Shin S, Merino M. Telephone-Based Guideline-Directed Medical Therapy Optimization in Navajo Nation: The Hozho Randomized Clinical Trial. JAMA Intern Med. 2024 Jun 1;184(6):681-690. doi: 10.1001/jamainternmed.2024.1523.
- Individual participant dataSharing planned: No. Patient data is protected by the Navajo Nation Human Research Board
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maricruz Merino, MD study director
Indian Health Service (IHS)
Lauren Eberly, MD, MPH principal investigator
Indian Health Service, Upenn
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR-based GDMT Optimization in people with Heart Failure, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage That Had Increase in Classes of Guideline Directed Medical Therapy (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05792085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.