Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

N/AWithdrawnNCT00319384

Hennepin Healthcare Research Institute

Overview

This trial will look at the effectiveness and patient acceptance of ultrafiltration therapy in an outpatient setting. The purpose of this study is to determine if ambulatory patients who suffer from heart failure and hypervolemia can be safely and effectively treated in an outpatient infusion clinic. The results from this trial will be useful in planning a larger, randomized trial comparing usual care and ultrafiltration for this patient population in similar ambulatory settings.

This is a pilot study to assess the feasibility, effectiveness, safety and patient acceptance of ultrafiltration in ambulatory patients with heart failure and hypervolemia. The results will be useful in planning a larger clinical trial.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Congestive Heart Failure

Interventions

Ultrafiltration therapyDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are: 1. Older than 18 2. Not pregnant 3. Have heart failure with worsening hypervolemia despite oral diuretics 4. Have at least two of the following signs or symptoms of hypervolemia: JVD, edema \>1+, rales pulmonary edema on chest x-ray, orthopnea or PND 5. Not more than 10 kg above their usual baseline weight 6. Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal Exclusion Criteria:  1. Systolic blood pressure \< 90 mmHg 2. Serum creatinine \> 3.0 mg/dL 3. Hematocrit \>45 % 4. Uncontrolled arrhythmias 5. Need for hospitalization 6. Require renal replacement therapy 7. Contraindication to anticoagulation with heparin 8. Poor venous access. \-

Locations (1)

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Efficacy

The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.

Secondary Outcomes

Quality of life will be assessed by the NYHA classification at 48 hours.

Likert scales addressing global heart failure and shortness of breath symptoms at 48 hours.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.