NCT06218199 · Heart Center Research, LLC
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts
(DART-HA)
What this study is about
The DART-HA study is a single-center, open label, trial intended to evaluate the clinical effectiveness 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Huntsville, Alabama
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2024 · Source of record for eligibility and locations