Heart Failure Clinical Trial
— GOALS-HFOfficial title:
Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure. (GOALS-HF)
Verified date | July 2023 |
Source | Tricog Health Inc |
Contact | Sameer Mathur |
Phone | 4698369145 |
sameer[@]tricog.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | November 10, 2023 |
Est. primary completion date | November 10, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | Manipal Hospital | Bengaluru | Karnataka |
India | Sakra World Hospital | Bengaluru | Karnataka |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Tricog Health Inc |
United States, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NT-ProBNP | 6-month follow-up | ||
Secondary | Changes in Diuretic Dose | 3-month, and 6-month follow-up | ||
Secondary | HF hospitalizations | 3-month, and 6-month follow-up | ||
Secondary | 6-min walk distance | 3-month, and 6-month follow-up | ||
Secondary | KCCQ | KCCQ overall score, and sub-scores. | 3-month, and 6-month. | |
Secondary | Atrial Fibrillation Anticoagulation Utilization | 3-month, and 6-month | ||
Secondary | HFpEF Medication Utilization | 3-month, and 6-month | ||
Secondary | composite HF Collaboratory GDMT score | 3-month, and 6-month |
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