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Completed

NCT Number: NCT05906745

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manipal Hospital, Bengaluru, Karnataka, India

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • >12 months of expected survival
  • Comfortable with spoken and written English communication
  • Access to Apple Watch-compatible iPhone

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. HF Hospitalizations

    Time frame: 3-month, and 6-month follow-up

    Hospitalizations for heart failure

  2. 6-min walk distance

    Time frame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up

    Six-minute walk test distance in meters

  3. KCCQ Overall Summary Score

    Time frame: The survey will be assessed at baseline, 1-month, 3-month, and 6-month follow-up.

    The KCCQ summary score ranges from 0 to 100, where higher scores indicate better quality of life.

  4. Atrial Fibrillation Anticoagulation Utilization

    Time frame: Baseline, 3-month, and 6-month

    Percentage of participants with atrial fibrillation indicated for anticoagulation that are on systemic anticoagulation.

  5. HFpEF Medication Utilization

    Time frame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up

    Percentage of participants on all three classes (ACEi/ARB/ARNI or MRA or SGLT2i)

  6. composite modified HF Collaboratory GDMT score

    Time frame: Baseline, 1-month follow-up, 3-month, and 6-month follow-up

    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.

  7. Changes in Diuretic Dose

    Time frame: 3-month, 6-month

    The number of days on higher than baseline dose of diuretic

Sponsors and collaborators

Lead sponsor

Tricog Health Inc

Industry

Registry information

Official study title

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

Acronym: GOALS-HF

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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