NCT06218199

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Heart Center Research, LLC · Network
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The DART-HA study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure diagnostic feature.

Detailed description

Subjects with congestive heart failure (CHF) who have undergone implantation of a Boston Scientific pacemaker/defibrillator with a HeartLogic sensor will be remotely monitored for for elevation of their HeartLogic score which is indicative of worsening heart failure. Subjects whose devices demonstrate HeartLogic score elevations and also do not demonstrate symptoms from heart failure will be randomized to observation or one of two standard treatments for worsening heart failure, afterload reduction or diuretic therapy. Subjects will be followed to assess the change in HeartLogic score, incidence of the the HeartLogic score returning to normal levels, the development of symptoms of heart failure and/or the need for treatment for heart failure.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DRUG	Furosemide	oral administration
DRUG	Torsemide	oral administration
DRUG	Bumetanide	oral administration
DRUG	sacubitril/valsartan	oral administration
DRUG	Hydralazine	oral administration
DRUG	Isosorbide Dinitrate	oral administration

Timeline

• Start date: 2021-07-08
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-01-23
• Last updated: 2024-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study