Clinical trial NCT05906745: Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure.
Official title: Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure. (GOALS-HF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Tricog Health Inc
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: NT-ProBNP
timeFrame: Baseline, week 2, 1-month follow-up, week 8, 3-month follow-up, week 16, week 20, 6-month follow-up
Secondary outcomes:
measure: HF Hospitalizations
timeFrame: 3-month, and 6-month follow-up
measure: 6-min walk distance
timeFrame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up
measure: KCCQ Overall Summary Score
timeFrame: The survey will be assessed at baseline, 1-month, 3-month, and 6-month follow-up.
measure: Atrial Fibrillation Anticoagulation Utilization
timeFrame: Baseline, 3-month, and 6-month
measure: HFpEF Medication Utilization
timeFrame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up
measure: composite modified HF Collaboratory GDMT score
timeFrame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up
measure: Changes in Diuretic Dose
timeFrame: 3-month, 6-month
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Bengaluru
country: India
facility: Manipal Hospital
state: Karnataka
city: Bengaluru
country: India
facility: Sakra World Hospital
state: Karnataka
Study officials:
References: