Comparing diuretics and afterload reduction for heart failure alerts
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)
This study is testing whether giving diuretics or a different type of heart treatment helps people with heart failure who have abnormal HeartLogic scores but no new symptoms feel better and avoid worsening their condition.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Heart Center Research, LLC Research network |
| Locations | 1 site (Huntsville, Alabama) |
| Trial ID | NCT06218199 on ClinicalTrials.gov |
What this trial studies
The DART-HA study evaluates the effectiveness of standard treatment options for congestive heart failure in patients who have abnormal HeartLogic scores but no new symptoms. Participants with implanted Boston Scientific devices will be monitored remotely for changes in their HeartLogic scores. Those with elevated scores will be randomized to receive either observation, diuretic therapy, or afterload reduction therapy. The study aims to assess changes in HeartLogic scores, the return to normal levels, and the development of heart failure symptoms.
Who should consider this trial
Good fit: Ideal candidates are patients with congestive heart failure who have a Boston Scientific device with HeartLogic enabled and meet specific inclusion criteria.
Not a fit: Patients experiencing ongoing symptoms of heart failure decompensation or with severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal treatment strategies for patients with worsening heart failure without new symptoms.
How similar studies have performed: Other studies have explored similar treatment approaches for heart failure, but this specific comparison of diuretics versus afterload reduction in asymptomatic patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Huntsville, Alabama
- Heart Center Research, LLC — Huntsville, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Jay Dinerman, MD — Heart Center Research, LLC
- Study coordinator: Coo
- Email: leskridge@theheartcenter.md
- Phone: 256-519-8472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.