Comparing diuretics and afterload reduction for heart failure alerts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.