RECRUITING

CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes

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 investigators aim to determine, using a point-of-care randomized controlled trial design, if hemodialysis patients, who are randomized to metoprolol succinate (a dialyzable, beta-1 selective beta blocker), have an improved cardiovascular outcome compared to those randomized to carvedilol (a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties). The investigators will also examine intervention practices to identify components that best support engagement and sustainability.

Official Title

CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)

Quick Facts

Study Start:2024-05-22
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05931276

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eligible patients are those (including men, women and minorities)
  2. * On hemodialysis
  3. * Received one of the following beta blockers through the VA pharmacy prescribed by a VA provider: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol, nadolol, pindolol, nebivolol
  1. * Impaired decision-making capacity
  2. * Patients not receiving carvedilol who have a history of asthma
  3. * known hypersensitivity to any component of either drug
  4. * Provider unwilling to sign a new medication order for a randomized patient
  5. * No surrogate consent will be allowed

Contacts and Locations

Study Contact

Jade Fiotto
CONTACT
(617) 232-9500
Jade.Fiotto@va.gov

Principal Investigator

Areef Ishani, MD MS
STUDY_CHAIR
Minneapolis VA Health Care System, Minneapolis, MN
James S Kaufman, MD
STUDY_CHAIR
VA NY Harbor Healthcare System, New York, NY

Study Locations (Sites)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
United States
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Areef Ishani, MD MS, STUDY_CHAIR, Minneapolis VA Health Care System, Minneapolis, MN
  • James S Kaufman, MD, STUDY_CHAIR, VA NY Harbor Healthcare System, New York, NY

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 Date2024-05-22
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-05-22
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Dialysis
  • beta-Blockers, Adrenergic
  • Cardiovascular Diseases
  • Point of Care Research
  • Comparative Effectiveness Research
  • Metoprolol Succinate
  • Carvedilol
  • Hemodialysis

Additional Relevant MeSH Terms

  • End-Stage Kidney Disease
  • End-Stage Renal Disease