Heart FailureGOALS-HFNCT05906745
Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure.
An observational study of Heart Failure, run by Tricog Health Inc at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 52 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 21 Jul 2023to 27 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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
Show all 9Show fewer
- >12 months of expected survival
- Comfortable with spoken and written English communication
- Access to Apple Watch-compatible iPhone
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
India2 sites
Manipal Hospital
Bengaluru, Karnataka, 560017
Sakra World Hospital
Bengaluru, Karnataka, 560103
About this study
Official title: 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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-ProBNP
Serum level of N-terminal pro B-type natriuretic peptide
Measured: 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
Hospitalizations for heart failure
Measured: 3-month, and 6-month follow-up
6-min walk distance
Six-minute walk test distance in meters
Measured: 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.
Measured: 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.
Measured: Baseline, 3-month, and 6-month
HFpEF Medication Utilization
Percentage of participants on all three classes (ACEi/ARB/ARNI or MRA or SGLT2i)
Measured: 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.
Measured: 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
Measured: 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start21 Jul 2023
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tricog Health Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906745
- Sponsor's protocol ID
- TR001
- Acronym
- GOALS-HF
- Status last verified
- Feb 2025
- First submitted
- 30 May 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure. (GOALS-HF)
- ClinicalTrials.gov ID
- NCT05906745
- Acronym / sponsor ID
- GOALS-HF / TR001
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tricog Health IncIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NT-ProBNP
Time frame: Baseline, week 2, 1-month follow-up, week 8, 3-month follow-up, week 16, week 20, 6-month follow-up
Serum level of N-terminal pro B-type natriuretic peptide
7 secondary outcomes
HF Hospitalizations
Time frame: 3-month, and 6-month follow-up
6-min walk distance
Time frame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up
KCCQ Overall Summary Score
Time frame: The survey will be assessed at baseline, 1-month, 3-month, and 6-month follow-up.
Atrial Fibrillation Anticoagulation Utilization
Time frame: Baseline, 3-month, and 6-month
HFpEF Medication Utilization
Time frame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up
composite modified HF Collaboratory GDMT score
Time frame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up
Changes in Diuretic Dose
Time frame: 3-month, 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
Recruiting
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Tricog Health Inc at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-ProBNP (time frame: Baseline, week 2, 1-month follow-up, week 8, 3-month follow-up, week 16, week 20, 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.