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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05906745

Acronym

GOALS-HF

Enrollment

Registered

2023-06-18

Start date

2023-07-21

Completion date

2024-09-27

Last updated

2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
NT-ProBNP	Baseline, week 2, 1-month follow-up, week 8, 3-month follow-up, week 16, week 20, 6-month follow-up	Serum level of N-terminal pro B-type natriuretic peptide

Secondary

Measure	Time frame	Description
6-min walk distance	Baseline, 1-month follow-up, 3-month, and 6-month follow-up	Six-minute walk test distance in meters
KCCQ Overall Summary Score	The survey will be assessed at baseline, 1-month, 3-month, and 6-month follow-up.	The KCCQ summary score ranges from 0 to 100, where higher scores indicate better quality of life.
Atrial Fibrillation Anticoagulation Utilization	Baseline, 3-month, and 6-month	Percentage of participants with atrial fibrillation indicated for anticoagulation that are on systemic anticoagulation.
HF Hospitalizations	3-month, and 6-month follow-up	Hospitalizations for heart failure
composite modified HF Collaboratory GDMT score	Baseline, 1-month follow-up, 3-month, and 6-month follow-up	2 points for optimal dosing of each medication class (beta-blockers, ACEi/ARB/ARNI, MRA, SGLT2i) and 1 point for suboptimal beta-blocker or ACEi/ARB dosing, expressed as a percentage of maximum possible points.
Changes in Diuretic Dose	3-month, 6-month	The number of days on higher than baseline dose of diuretic
HFpEF Medication Utilization	Baseline, 1-month follow-up, 3-month, and 6-month follow-up	Percentage of participants on all three classes (ACEi/ARB/ARNI or MRA or SGLT2i)

Countries

India, United States

Outcome results