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

Completed

• Conditions: Heart Failure

• Registration Number: NCT05906745
• Lead Sponsor: Tricog Health Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-18
• Study Start: 2023-07-21
• Primary Completion: 2024-09-27
• Study Completion: 2024-09-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
HF Hospitalizations	3-month, and 6-month follow-up	Hospitalizations for heart failure
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.
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)
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

Trial Locations

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