RECRUITING

Diuretics Alone Vs. Aortix Endovascular Device for Acute Heart Failure

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Conditions

Heart FailureCardiorenal SyndromeCardio-Renal SyndromeADHFHeart Failure, SystolicHeart Failure, DiastolicHeart Failure; with DecompensationHeart Failure, Congestivemechanical circulatory supportpercutaneous

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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

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.

Official Title

DRAIN-HF: Diuretics Alone Vs. Aortix Endovascular Device for Acute Heart Failure

Quick Facts

Study Start:2023-08-23
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05677100

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:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Rubi Reyes-Fuentez
CONTACT
832-536-1601
rubi@procyrion.com

Study Locations (Sites)

Birmingham VA Health Care System
Birmingham, Alabama, 35233
United States
Banner--University Medical Center Phoenix
Phoenix, Arizona, 85006
United States
HonorHealth Medical Center
Scottsdale, Arizona, 85258
United States
John Muir Health
Concord, California, 94520
United States
Zuckerberg San Francisco General
San Francisco, California, 94110
United States
San Francisco Veterans Administration
San Francisco, California, 94121
United States
University of California San Francisco
San Francisco, California, 94143
United States
Ascension Sacred Heart
Pensacola, Florida, 32504
United States
Tallahassee Research Institute
Tallahassee, Florida, 32308
United States
University of South Florida
Tampa, Florida, 33606
United States
AdventHealth Tampa
Tampa, Florida, 33613
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Emory University Hospital
Atlanta, Georgia, 30308
United States
Piedmont Healthcare Inc.
Augusta, Georgia, 30309
United States
Wellstar Research Institue
Marietta, Georgia, 30060
United States
Advocate IMMC
Chicago, Illinois, 60657
United States
Advocate Aurora - Good Samaritan
Downers Grove, Illinois, 60515
United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
United States
University of Michigan, Cardiovascular Medicine
Ann Arbor, Michigan, 48109
United States
Henry Ford
Detroit, Michigan, 48202
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
United States
New York Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New York, 11215
United States
Nyph/Cumc
New York City, New York, 10032
United States
Mount Sinai Morningside
New York, New York, 10025
United States
Northwell Health (Lenox Hill)
New York, New York, 10075
United States
Nuvance Health
Poughkeepsie, New York, 12601
United States
Northwell Health (Staten Island)
Staten Island, New York, 10305
United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
United States
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
United States
Oregon Health & Sciences University
Portland, Oregon, 97239
United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001
United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18102
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
Baylor Scott & White Research Institute
Forth Worth, Texas, 76104
United States
Texas Heart Institute
Houston, Texas, 77030
United States
Intermountain Health
Murray, Utah, 84107
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Procyrion

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 Date2023-08-23
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-08-23
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • mechanical circulatory support
  • percutaneous

Additional Relevant MeSH Terms

  • Heart Failure
  • Cardiorenal Syndrome
  • Cardio-Renal Syndrome
  • ADHF
  • Heart Failure, Systolic
  • Heart Failure, Diastolic
  • Heart Failure; with Decompensation
  • Heart Failure, Congestive