NCT06218199 Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
| NCT ID | NCT06218199 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Heart Center Research, LLC |
| Condition | Heart Failure, Congestive |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-07-08 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2021-07-08 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Boston Scientific device with HeartLogic enabled * Lack of standard contraindications to Sacubitril/valsartan: * history of ACE-inhibitor induced angioedema and in those with angiotensin II receptor blocker (ARB) therapy induced angioedema. * hypotension, hypovolemia * renal artery stenosis, renal failure * hyperkalemia * hepatic disease Child-Pugh class C * Pregnancy/Breast-feeding * Lack of standard contraindications to diuretic therapy * Systolic Blood Pressure \> 105 Exclusion Criteria: * Glomerular filtration rate \<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis * ongoing symptoms of heart failure decompensation (increased dyspnea and/or fatigue, for purposes of this study increased weight is not considered, see question 2 KCCQ). * recent significant change in arrhythmia burden (within the past 2 weeks) * in cardiac resynchronization therapy (CRT) patients, recent change (60 days) in effective delivery of CRT (eg. decreased biventricular paving %) * the subject is unable to sign or refuses to sign the patient informed consent * Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment * the subject is implanted with unipolar right atrial or right ventricular leads * subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months * subject is pregnant or planning to become pregnant during the study * regularly scheduled IV heart failure therapy (e.g. inotropes or diuretics)
Contact & Investigator
Jay Dinerman, MD
PRINCIPAL INVESTIGATOR
Heart Center Research, LLC
Frequently Asked Questions
Who can join the NCT06218199 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Heart Failure, Congestive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06218199 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06218199 currently recruiting?
Yes, NCT06218199 is actively recruiting participants. Contact the research team at leskridge@theheartcenter.md for enrollment information.
Where is the NCT06218199 trial being conducted?
This trial is being conducted at Huntsville, United States.
Who is sponsoring the NCT06218199 clinical trial?
NCT06218199 is sponsored by Heart Center Research, LLC. The principal investigator is Jay Dinerman, MD at Heart Center Research, LLC. The trial plans to enroll 80 participants.
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