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New treatment option for Heart Failure, Congestive
Official title Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
ClinicalTrials.gov ID: NCT06218199
What this study is testing
What is Furosemide?
Furosemide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart failure, congestive.
Also referred to as Lasix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.