Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment (AVOID-HF)

Nuwellis

Status: Terminated

Conditions: Cardiac Failure; Acute Decompensated Heart Failure (ADHF); Heart Failure

Treatments: Drug: IV Loop Diuretics (LD); Device: Isolated veno-venous ultrafiltration (AQ)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474200

1494

Details and patient eligibility

About

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 from the hospital. Heart Failure events are defined as returning to the hospital, clinic or emergency department (ED) for treatment of HF symptoms.

Full 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 the "Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure" (UNLOAD) study, the 90 day HF re-hospitalizations were pre-specified secondary end-points. AVOID-HF is designed with a primary end-point to determine if AQ reduces the number of HF events (Rehospitalization or unscheduled outpatient or emergency room treatment for HF) after discharge from index hospitalization compared to IV loop diuretics. AVOID will also explore days alive and out of the hospital as a secondary end-point, which was not done in UNLOAD. In other words, the AVOID-HF study is going beyond studying only the amount of fluid removal and will explore whether the modality of fluid removal influences HF outcomes.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older

2. Male or non-pregnant female patients

3. Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)

4. On regularly scheduled oral loop diuretics prior to admission

5. Fluid overload manifested by at least two of the following:

   1. Pitting edema (2+) of the lower extremities
   2. Jugular venous distention > 8 cm
   3. Pulmonary edema or pleural effusion on chest x-ray
   4. Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
   5. Respiration rate ≥ 20 per minute.

6. Have received ≤ 2 IV loop diuretics doses before randomization

7. Must be able to be enrolled into the trial ≤ 24 hours of their admission to the hospital.

8. Provide written informed consent form as required by the local IRB (Institutional Review Board)

Exclusion criteria

1. Acute coronary syndromes
2. Renal insufficiency with a sCr ≥ 3.0 mg/dl or planned renal replacement therapies
3. Systolic blood pressure < 90 mmHg at time of enrollment
4. Pulmonary Arterial Hypertension not secondary to left heart disease
5. Contraindications to systemic anticoagulation
6. Hematocrit > 45%
7. Inability to obtain venous access
8. Hemodynamic instability severe enough to require IV positive inotropic agents, IV vasodilators or both
9. Use of iodinated radiocontrast material within the previous 72 hours or planned study requiring IV contrast during the current hospitalization
10. Severe concomitant disease expected to prolong hospitalization
11. Severe concomitant disease expected to cause death in ≤ 90 days
12. Sepsis or ongoing systemic infection
13. Severe uncorrected valvular stenosis
14. Active myocarditis
15. Hypertrophic obstructive cardiomyopathy
16. Constrictive pericarditis or restrictive cardiomyopathy
17. Liver cirrhosis
18. Previous solid organ transplant
19. Requirement for mechanical ventilatory support
20. Presence of a mechanical circulatory support device
21. Unwillingness or inability to complete follow up
22. Active drug or ETOH substance abuse
23. Participating in another interventional clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Aquapheresis (AQ) - isolated veno-venous ultrafiltration

Experimental group

Description:

Excess fluid from the patient is removed by isolated veno-venous ultrafiltration treatment using the Aquadex Flex Flow System

Treatment:

Device: Isolated veno-venous ultrafiltration (AQ)

IV Loop Diuretics (LD)

Active Comparator group

Description:

Excess fluid from the patient is removed by IV (Intravenous) loop diuretic treatment

Treatment:

Drug: IV Loop Diuretics (LD)