Status:
TERMINATED
Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment
Lead Sponsor:
Nuwellis, Inc.
Conditions:
Heart Failure
Cardiac Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the research is to determine if patients have fewer Heart Failure (HF) events after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90 days of discharge...
Detailed Description
The aim of the proposed AVOID-HF study is to confirm and expand the findings that fluid removal by AQ reduces HF rehospitalizations at 90 days as well as the length of these HF rehospitalizations. In ...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Male or non-pregnant female patients
- Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)
- On regularly scheduled oral loop diuretics prior to admission
- Fluid overload manifested by at least two of the following:
- Pitting edema (2+) of the lower extremities
- Jugular venous distention \> 8 cm
- Pulmonary edema or pleural effusion on chest x-ray
- Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
- Respiration rate ≥ 20 per minute.
- Have received ≤ 2 IV loop diuretics doses before randomization
- Must be able to be enrolled into the trial ≤ 24 hours of their admission to the hospital.
- Provide written informed consent form as required by the local IRB (Institutional Review Board)
Exclusion
- Acute coronary syndromes
- Renal insufficiency with a sCr ≥ 3.0 mg/dl or planned renal replacement therapies
- Systolic blood pressure \< 90 mmHg at time of enrollment
- Pulmonary Arterial Hypertension not secondary to left heart disease
- Contraindications to systemic anticoagulation
- Hematocrit \> 45%
- Inability to obtain venous access
- Hemodynamic instability severe enough to require IV positive inotropic agents, IV vasodilators or both
- Use of iodinated radiocontrast material within the previous 72 hours or planned study requiring IV contrast during the current hospitalization
- Severe concomitant disease expected to prolong hospitalization
- Severe concomitant disease expected to cause death in ≤ 90 days
- Sepsis or ongoing systemic infection
- Severe uncorrected valvular stenosis
- Active myocarditis
- Hypertrophic obstructive cardiomyopathy
- Constrictive pericarditis or restrictive cardiomyopathy
- Liver cirrhosis
- Previous solid organ transplant
- Requirement for mechanical ventilatory support
- Presence of a mechanical circulatory support device
- Unwillingness or inability to complete follow up
- Active drug or ETOH substance abuse
- Participating in another interventional clinical trial
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT01474200
Start Date
January 1 2012
End Date
July 1 2014
Last Update
August 29 2023
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Heart Center Research
Huntsville, Alabama, United States, 35801
2
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85054
3
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States, 85258
4
UCLA
Los Angeles, California, United States, 90095