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

NCT05906745 | Completed

• 1 other identifier: TR001
• Study Type: observational
• Target: 52
• Locations: 2 countries
• Sites: 4

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• NT-ProBNP

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

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

Secondary Outcomes (7)

• HF Hospitalizations

  3-month, and 6-month follow-up

• 6-min walk distance

  Baseline, 1-month follow-up, 3-month, and 6-month follow-up

• KCCQ Overall Summary Score

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

• Atrial Fibrillation Anticoagulation Utilization

  Baseline, 3-month, and 6-month

• HFpEF Medication Utilization

  Baseline, 1-month follow-up, 3-month, and 6-month follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults hospitalized for decompensated heart failure or in the post-discharge period following a heart failure hospitalization will be eligible for enrollment. Participants that meet eligibility criteria will be enrolled consecutively. Heart Failure with preserved ejection Fraction (HFpEF) will be defined by EF ≥ 50% at the time of HF diagnosis. Heart Failure with reduced ejection fraction (HFrEF) will be defined by EF \<40%, and patients with EF between 40-49% will be identified as Heart Failure with mildly reduced EF (HFmrEF).

You may qualify if:

• Age ≥ 18 years
• Recent hospitalization (within 4 weeks of enrollment) for HF with IV diuretic use
• Echocardiographic data with EF measurements available in the last 6 months and after HF diagnosis
• Established outpatient care at the participating sites
• 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
• Not on Target GDMT for all the eligible GDMT classes
• \>12 months of expected survival
• Comfortable with spoken and written English communication
• Access to Apple Watch-compatible iPhone

You may not qualify if:

• Under consideration for or recipient of advanced heart failure therapies (LVAD, Transplant)
• Current or anticipated use of home intravenous inotrope therapy.
• Unwilling or unable to perform all study related procedures (wear watch, take measurements and maintain daily logs)
• Post-discharge placement in nursing, rehabilitation, or long-term care facility
• Planned (within next 6 months) surgery
• Inability to provide written consent

Sponsors & Collaborators

• Tricog Health Inc: lead

Study Sites (4)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Manipal Hospital

Bengaluru, Karnataka, 560017, India

Location

Sakra World Hospital

Bengaluru, Karnataka, 560103, India

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 18, 2023
• Study Start: July 21, 2023
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2); US (2)