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

Heart Failure Clinical Trial

— GOALS-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05906745
• Other study ID #: TR001
• Status: Not yet recruiting
• Start date: July 20, 2023
• Est. completion date: November 10, 2023

Study information

• Verified date: July 2023
• Source: Tricog Health Inc
• Contact: Sameer Mathur
• Phone: 4698369145
• Email: sameer[@]tricog.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2023
• 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

Related Conditions & MeSH terms

• Heart Failure

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tricog Health Inc

Countries where clinical trial is conducted

United States,  India, 

Outcome

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