RECRUITING

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

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Conditions

Heart Failure, Congestive

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)

Quick Facts

Study Start:2021-07-08
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06218199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Boston Scientific device with HeartLogic enabled
  2. * Lack of standard contraindications to Sacubitril/valsartan:
  3. * history of ACE-inhibitor induced angioedema and in those with angiotensin II receptor blocker (ARB) therapy induced angioedema.
  4. * hypotension, hypovolemia
  5. * renal artery stenosis, renal failure
  6. * hyperkalemia
  7. * hepatic disease Child-Pugh class C
  8. * Pregnancy/Breast-feeding
  9. * Lack of standard contraindications to diuretic therapy
  10. * Systolic Blood Pressure \> 105
  1. * Glomerular filtration rate \<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
  2. * 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).
  3. * recent significant change in arrhythmia burden (within the past 2 weeks)
  4. * in cardiac resynchronization therapy (CRT) patients, recent change (60 days) in effective delivery of CRT (eg. decreased biventricular paving %)
  5. * the subject is unable to sign or refuses to sign the patient informed consent
  6. * Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
  7. * the subject is implanted with unipolar right atrial or right ventricular leads
  8. * subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
  9. * subject is pregnant or planning to become pregnant during the study
  10. * regularly scheduled IV heart failure therapy (e.g. inotropes or diuretics)

Contacts and Locations

Study Contact

COO
CONTACT
256-519-8472
leskridge@theheartcenter.md

Principal Investigator

Jay Dinerman, MD
PRINCIPAL_INVESTIGATOR
Heart Center Research, LLC

Study Locations (Sites)

Heart Center Research, LLC
Huntsville, Alabama, 35801
United States

Collaborators and Investigators

Sponsor: Heart Center Research, LLC

  • Jay Dinerman, MD, PRINCIPAL_INVESTIGATOR, Heart Center Research, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-08
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-07-08
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure, Congestive