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

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

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 Overview

• Status: Completed
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 560017
      • Manipal Hospital
    • Bengaluru, Karnataka, India, 560103
      • Sakra World Hospital
• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HF Hospitalizations	Hospitalizations for heart failure	3-month, and 6-month follow-up
6-min walk distance	Six-minute walk test distance in meters	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.	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.	Baseline, 3-month, and 6-month
HFpEF Medication Utilization	Percentage of participants on all three classes (ACEi/ARB/ARNI or MRA or SGLT2i)	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.	Baseline, 1-month follow-up, 3-month, and 6-month follow-up
Changes in Diuretic Dose	The number of days on higher than baseline dose of diuretic	3-month, 6-month

Collaborators and Investigators

• Sponsor: Tricog Health Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: TR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No