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NCT Number: NCT05792085

Heart Failure Optimization at Home to Improve Outcomes (Hozho): A Pragmatic Clinical Trial 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gallup Indian Medical Center, Gallup, New Mexico, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EHR-based GDMT Optimization

Behavioral

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Percentage That Had Increase in Classes of Guideline Directed Medical Therapy or Dose of Guideline Directed Medical Therapy

    Time frame: 30 days

    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)

  2. Rates of Increase/Addition of ACEi/ARB/Angiotensin Receptor-Neprilysin Inhibitor

    Time frame: 30 days

    Rates of Rx for ACEi, ARB, or ANRI (Sacubritril-Valsartan)

  3. Rates of Increase/Addition in Sodium-glucose Co-transporter 2 Inhibitors

    Time frame: 30 days

    Rates of Rx for Sodium-glucose co-transporter 2 inhibitors

  4. Rates of Increase/Addition of Aldosterone Receptor Antagonists

    Time frame: 30 days

    Rates of Rx for Aldosterone receptor antagonists

  5. Rates of Increase/Addition of Beta-blockers

    Time frame: 30 days

    Rates of Rx for Beta-blockers

  6. Addition of or Increase in Dose for ACEi/ARB/ARNI

    Time frame: 30 days

    Increase in Dose for ACEi/ARB/ARNI

  7. Addition of or Increase in Dose of Beta-blocker

    Time frame: 30 days

    Addition of or Increase in Dose for Beta-blocker

  8. Addition of or Increase in Dose of Aldosterone Receptor Antagonists

    Time frame: 30 days

    Dose increase or addition of Aldosterone receptor antagonists

Other outcomes

  1. Change in Provider Comfort With Guideline Directed Medical Therapy Prescribing From Baseline to 6 Months

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Indian Health Service (IHS)

Registry information

Official study title

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

Acronym: Hozho

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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