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

Tricog Health Inc52 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Duke University Medical Center

Durham, North Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Manipal Hospital

Bengaluru, Karnataka, India

Sakra World Hospital

Bengaluru, Karnataka, India

Outcomes

Primary Outcomes

NT-ProBNP

Serum level of N-terminal pro B-type natriuretic peptide

Time frame: Baseline, week 2, 1-month follow-up, week 8, 3-month follow-up, week 16, week 20, 6-month follow-up

Secondary Outcomes

HF Hospitalizations

Hospitalizations for heart failure

Time frame: 3-month, and 6-month follow-up

6-min walk distance

Six-minute walk test distance in meters

Time frame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up

KCCQ Overall Summary Score

The KCCQ summary score ranges from 0 to 100, where higher scores indicate better quality of life.

Time frame: The survey will be assessed at baseline, 1-month, 3-month, and 6-month follow-up.

Atrial Fibrillation Anticoagulation Utilization

Percentage of participants with atrial fibrillation indicated for anticoagulation that are on systemic anticoagulation.

Time frame: Baseline, 3-month, and 6-month

HFpEF Medication Utilization

Percentage of participants on all three classes (ACEi/ARB/ARNI or MRA or SGLT2i)

Time frame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up

composite modified HF Collaboratory GDMT score

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.

Time frame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up

Data from ClinicalTrials.gov

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