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GOALS-HF: Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure.

Sponsor
Tricog Health Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05906745
Collaborator
(none)
150
Enrollment
4
Locations
5
Anticipated Duration (Months)
37.5
Patients Per Site
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A multicenter, non-randomized prospective longitudinal study to evaluate the feasibility of Tricog's Remote platform for Guideline Directed Medical Therapy (GDMT) titration and remote patient monitoring among patients with Heart Failure.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure. (GOALS-HF)
    Anticipated Study Start Date :
    Jun 10, 2023
    Anticipated Primary Completion Date :
    Nov 10, 2023
    Anticipated Study Completion Date :
    Nov 10, 2023

    Outcome Measures

    Primary Outcome Measures

    1. NT-ProBNP [6-month follow-up]

    Secondary Outcome Measures

    1. Changes in Diuretic Dose [3-month, and 6-month follow-up]

    2. HF hospitalizations [3-month, and 6-month follow-up]

    3. 6-min walk distance [3-month, and 6-month follow-up]

    4. KCCQ [3-month, and 6-month.]

      KCCQ overall score, and sub-scores.

    5. Atrial Fibrillation Anticoagulation Utilization [3-month, and 6-month]

    6. HFpEF Medication Utilization [3-month, and 6-month]

    7. composite HF Collaboratory GDMT score [3-month, and 6-month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Age ≥ 18 years

    2. Recent hospitalization (within 4 weeks of enrollment) for HF with IV diuretic use

    3. Echocardiographic data with EF measurements available in the last 6 months and after HF diagnosis

    4. Established outpatient care at the participating sites

    5. Eligible to receive at least 2 of the 4 GDMT classes (ACEi/ARB/ARNi, Beta-blockers, MRA, and SGLT2i) for HFrEF and HFmrEF and at least one of the three (ARB/ARNI, MRA, SGLT2i) for HFpEF

    6. Not on Target GDMT for all the eligible GDMT classes

    7. 12 months of expected survival

    8. Comfortable with spoken and written English communication

    9. Access to Apple Watch-compatible iPhone

    Exclusion Criteria:

    1. Under consideration for or recipient of advanced heart failure therapies (LVAD, Transplant)

    2. Current or anticipated use of home intravenous inotrope therapy.

    3. Unwilling or unable to perform all study related procedures (wear watch, take measurements and maintain daily logs)

    4. Post-discharge placement in nursing, rehabilitation, or long-term care facility

    5. Planned (within next 6 months) surgery

    6. Inability to provide written consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710
    2 UT Southwestern Medical Center Dallas Texas United States 75390
    3 Manipal Hospital Bengaluru Karnataka India 560017
    4 Sakra World Hospital Bengaluru Karnataka India 560103

    Sponsors and Collaborators

    • Tricog Health Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tricog Health Inc
    ClinicalTrials.gov Identifier:
    NCT05906745
    Other Study ID Numbers:
    • TR001
    First Posted:
    Jun 18, 2023
    Last Update Posted:
    Jun 18, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jun 18, 2023