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Search / Trial NCT04572867

Aquapheresis Efficacy in Outpatients With Decompensated Heart Failure

Launched by RAMONA GELZER BELL · Sep 29, 2020

Trial Information

Current as of May 06, 2025

Withdrawn

Keywords

Aquapheresis Diuresis

ClinConnect Summary

Congestive heart failure (CHF) affects nearly 2% of the U.S. population, with almost 1 million hospital admissions for acute decompensated CHF annually. Congestive heart failure is the most frequent cause of hospitalization in patients over the age of 65. Patients admitted for acute decompensated heart failure (ADHF) have a high 6-month readmission rate for acute CHF, ranging from 23% to 40% in different studies. It is estimated that 25 to 30% of these patients are diuretic resistant with 50% of patients losing less than 5 lbs. from admission weight and 20% actually gaining weight during th...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subjects must be 18 years of age or older already on standard of care therapy including Angiotensin Converting Enzyme Inhibitors (ACE-I), Angiotensin
  • Receptor Blockers (ARBs), Sacubitril/Valsartan, beta-blocker, oral diuretic (80 mg Lasix/2 mg Bumex/40 mg Torsemide+/-Thiazide diuretic), and meet the following inclusion criteria to be enrolled:
  • Inclusion Criteria:
  • 1. CHF refractory to oral diuretic (80mg Lasix, 2mg Bumex, or 40mg Torsemide)
  • 2. Volume overload secondary to systolic or diastolic HF, evidenced by at least 2 of the following:
  • 1. Elevated BNP (\>100)
  • 2. Paroxysmal nocturnal dyspnea or orthopnea
  • 3. Elevated jugular venous distention (\>/ 7 cm)
  • 4. X-ray findings consisted with CHF
  • 5. Presence of ascites or LE edema . -
  • Exclusion Criteria:
  • 1. Acute Coronary Syndrome
  • 2. Hypertensive urgency or emergency
  • 3. Rapid atrial fibrillation difficult to control
  • 4. Contraindication to anticoagulation
  • 5. Pregnancy
  • 6. Requires hemodialysis (\> CR \> 3.0 mg/dl)
  • 7. Symptomatic hypotension
  • 8. Poor venous access
  • 9. Pressor dependent. -

About Ramona Gelzer Bell

Ramona Gelzer Bell is a dedicated clinical trial sponsor committed to advancing medical research and enhancing patient outcomes through innovative study designs and rigorous methodologies. With a focus on collaboration and integrity, the organization strives to support the development of new therapies and interventions across various therapeutic areas. By fostering partnerships with research institutions and healthcare providers, Ramona Gelzer Bell aims to facilitate the efficient progression of clinical trials, ensuring the highest standards of safety and efficacy in the quest for improved healthcare solutions.

Locations

Patients applied

0 patients applied

Trial Officials

Ramona Gelzer Bell, MD

Principal Investigator

James A. Haley Veterans Administration Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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