NCT06218199RecruitingPhase 4
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)
Source: ClinicalTrials.gov · Last updated 29 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 11 Jan 2024
- Start date
- 8 Jul 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Heart Center Research, LLC
- Diseases
- Heart failure
- NCT number
- NCT06218199
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From 8 Jul 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Glomerular filtration rate \<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
- subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
Other illness
- 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 %)
- Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
- regularly scheduled IV heart failure therapy (e.g. inotropes or diuretics)
Other
- the subject is unable to sign or refuses to sign the patient informed consent
- the subject is implanted with unipolar right atrial or right ventricular leads
- subject is pregnant or planning to become pregnant during the study
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heart Center Research, LLC Coordinator of this site? Confirm its status | Huntsville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.