Heart Failure Clinical Trial
Official title:
Efficacy of Aquapheresis in Patients Treated as Outpatients With Decompensated Heart Failure at a Veterans Hospital
NCT number | NCT04572867 |
Other study ID # | AQUA |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 8, 2021 |
Est. completion date | July 27, 2021 |
Verified date | August 2021 |
Source | James A. Haley Veterans Administration Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
With this research the Investigators hope to learn if early aquapheresis in an outpatient setting will improve congestive heart failure symptoms in outpatients with decompensated heart failure who have been refractory to high dose diuretics. In previous trials in inpatient settings, aquapheresis has been demonstrated to improve quality of life and reduce hospital visits for those who have undergone the treatment. This study is one of the first to evaluate the effectiveness of aquapheresis in veterans with congestive heart failure in an outpatient setting. The aquapheresis device, Aquadex FlexFlow® System, manufactured by CHF Solutions™, Minneapolis, MN, has been approved by the Food and Drug Administration (FDA) for removing excess sodium and fluid from patients suffering from volume overload, like in congestive heart failure.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 27, 2021 |
Est. primary completion date | July 27, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. - |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ramona Gelzer Bell |
Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. — View Citation
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Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Hospitalizations by 7 days post-treatment | Compare number of hospitalization readmissions for CHF between Intervention (Aquaphersis arm) & Control groups | Between outpatient treatment and 7-days after outpatient treatment | |
Primary | Number of Hospitalizations by 30 days post-treatment | Compare number of hospitalization readmissions for CHF between Intervention (Aquaphersis arm) & Control groups | Between outpatient treatment and 30 days after outpatient treatment | |
Primary | Number of Hospitalizations by 60 days post-treatment | Compare number of hospitalization readmissions for CHF between Intervention (Aquaphersis arm) & Control groups | Between outpatient treatment and 60 days after outpatient treatment | |
Primary | Number of Hospitalizations by 90 days post-treatment | Compare number of hospitalization readmissions for CHF between Intervention (Aquaphersis arm) & Control groups | Between outpatient treatment and 90 days after outpatient treatment | |
Primary | Weight change by 7 days post-treatment | Compare weight change (pounds) in patients between Intervention & Control groups | Outpatient treatment to 7 days after outpatient treatment | |
Primary | Weight change by 30 days post-treatment | Compare weight change (pounds) in patients between Intervention & Control groups | Outpatient treatment to 30 days after outpatient treatment | |
Primary | Weight change by 60 days post-treatment | Compare weight change (pounds) in patients between Intervention & Control groups | Outpatient treatment to 60 days after outpatient treatment | |
Primary | Weight change by 90 days post-treatment | Compare weight change (pounds) in patients between Intervention & Control groups | Outpatient treatment to 90 days after outpatient treatment | |
Secondary | Total fluid removal | Compare total fluid removal (ml) in patients between Intervention & Control groups | Baseline (Randomization) to outpatient discharge | |
Secondary | Blood urea nitrogen at Baseline | Compare Blood urea nitrogen (BUN; mg/dl) (higher than normal range is worse) in patients between Intervention & Control groups | Baseline (Randomization) | |
Secondary | Blood urea nitrogen at 7 days post-treatment | Compare Blood urea nitrogen (BUN; mg/dl) (higher than normal range is worse) in patients between Intervention & Control groups | 7 days after outpatient treatment | |
Secondary | Blood urea nitrogen at 30 days post-treatment | Compare Blood urea nitrogen (BUN; mg/dl) (higher than normal range is worse)) in patients between Intervention & Control groups | 30 days after outpatient treatment | |
Secondary | Blood urea nitrogen at 60 days post-treatment | Compare Blood urea nitrogen (BUN; mg/dl) (higher than normal range is worse) in patients between Intervention & Control groups | 60 days after outpatient treatment | |
Secondary | Blood urea nitrogen at 90 days post-treatment | Compare Blood urea nitrogen (BUN; mg/dl) (higher than normal range is worse) in patients between Intervention & Control groups | 90 days after outpatient treatment | |
Secondary | Creatinine at Baseline | Compare Creatinine (Cr; mg/dl) (higher than normal range is worse) in patients between Intervention & Control groups | Baseline (Randomization) | |
Secondary | Creatinine at 7 days post-treatment | Compare Creatinine (Cr; mg/dl) (higher than normal range is worse) in patients between Intervention & Control groups | 7 days after outpatient treatment | |
Secondary | Creatinine at 30 days post-treatment | Compare Creatinine (Cr; mg/dl) (higher than normal range is worse) in patients between Intervention & Control groups | 30 days after outpatient treatment | |
Secondary | Creatinine at 60 days post-treatment | Compare Creatinine (Cr; mg/dl) (higher than normal range is worse) in patients between Intervention & Control groups | 60 days after outpatient treatment | |
Secondary | Creatinine at 90 days post-treatment | Compare Creatinine (Cr; mg/dl) (higher than normal range is worse) in patients between Intervention & Control groups | 90 days after outpatient treatment | |
Secondary | Glomerular filtration rate at Baseline | Compare Glomerular filtration rate (GFR; ml/min/1.73 meters squared) (lower than normal range is worse) in patients between Intervention & Control groups | Baseline (Randomization) | |
Secondary | Glomerular filtration rate at 7 days post-treatment | Compare Glomerular filtration rate (GFR; ml/min/1.73 meters squared) (lower than normal range is worse) in patients between Intervention & Control groups | 7 days after outpatient treatment | |
Secondary | Glomerular filtration rate at 30 days post-treatment | Compare Glomerular filtration rate (GFR; ml/min/1.73 meters squared) (lower than normal range is worse) in patients between Intervention & Control groups | 30 days after outpatient treatment | |
Secondary | Glomerular filtration rate at 60 days post-treatment | Compare Glomerular filtration rate (GFR; ml/min/1.73 meters squared) (lower than normal range is worse) in patients between Intervention & Control groups | 60 days after outpatient treatment | |
Secondary | Glomerular filtration rate at 90 days post-treatment | Compare Glomerular filtration rate (GFR; ml/min/1.73 meters squared) (lower than normal range is worse) in patients between Intervention & Control groups | 90 days after outpatient treatment | |
Secondary | Brain natriuretic peptide (BNP) test at Baseline | Compare BNP (pg/ml of blood) (higher than normal range is worse) in patients between Intervention & Control groups | Baseline (Randomization) | |
Secondary | Brain natriuretic peptide (BNP) test at 7 days post-treatment | Compare BNP (pg/ml of blood) (higher than normal range is worse) in patients between Intervention & Control groups | 7 days after outpatient treatment | |
Secondary | Brain natriuretic peptide (BNP) test at 30 days post-treatment | Compare BNP (pg/ml of blood) (higher than normal range is worse) in patients between Intervention & Control groups | 30 days after outpatient treatment | |
Secondary | Brain natriuretic peptide (BNP) test at 60 days post-treatment | Compare BNP (pg/ml of blood) (higher than normal range is worse) in patients between Intervention & Control groups | 60 days after outpatient treatment | |
Secondary | Brain natriuretic peptide (BNP) test at 90 days post-treatment | Compare BNP (pg/ml of blood) (higher than normal range is worse) in patients between Intervention & Control groups | 90 days after outpatient treatment | |
Secondary | 6-minute Walk Test at Baseline | Compare 6-minute Walk Test (meters/6 minutes; less distance means more disability) in patients between Intervention & Control groups | Baseline (Randomization) | |
Secondary | 6-minute Walk Test at 7 days post-treatment | Compare 6-minute Walk Test (meters/6 minutes; less distance means more disability) in patients between Intervention & Control groups | 7 days after outpatient treatment | |
Secondary | 6-minute Walk Test at 30 days post-treatment | Compare 6-minute Walk Test (meters/6 minutes; less distance means more disability) in patients between Intervention & Control groups | 30 days after outpatient treatment | |
Secondary | 6-minute Walk Test at 60 days post-treatment | Compare 6-minute Walk Test (meters/6 minutes; less distance means more disability) in patients between Intervention & Control groups | 60 days after outpatient treatment | |
Secondary | 6-minute Walk Test at 90 days post-treatment | Compare 6-minute Walk Test (meters/6 minutes; less distance means more disability) in patients between Intervention & Control groups | 90 days after outpatient treatment | |
Secondary | Minnesota Living with Heart Failure Questionnaire (MLWHFQ) | Compare Minnesota Living with Heart Failure Questionnaire (MLWHFQ) (total score; higher score means more impairment) in patients between Intervention & Control groups | Baseline (Randomization) | |
Secondary | Minnesota Living with Heart Failure Questionnaire (MLWHFQ) | Compare Minnesota Living with Heart Failure Questionnaire (MLWHFQ) (total score; higher score means more impairment) in patients between Intervention & Control groups | 7 days after outpatient treatment | |
Secondary | Minnesota Living with Heart Failure Questionnaire (MLWHFQ) | Compare Minnesota Living with Heart Failure Questionnaire (MLWHFQ) (total score; higher score means more impairment) in patients between Intervention & Control groups | 30 days after outpatient treatment | |
Secondary | Minnesota Living with Heart Failure Questionnaire (MLWHFQ) | Compare Minnesota Living with Heart Failure Questionnaire (MLWHFQ) (total score; higher score means more impairment) in patients between Intervention & Control groups | 60 days after outpatient treatment | |
Secondary | Minnesota Living with Heart Failure Questionnaire (MLWHFQ) | Compare Minnesota Living with Heart Failure Questionnaire (MLWHFQ) (total score; higher score means more impairment) in patients between Intervention & Control groups | 90 days after outpatient treatment | |
Secondary | SF-36 at Baseline | Compare SF-36 weighted sums (0-100 scale; lower score means more disability) in patients between Intervention & Control groups | Baseline (Randomization) | |
Secondary | SF-36 at 7 days post-treatment | Compare SF-36 weighted sums (0-100 scale; lower score means more disability) in patients between Intervention & Control groups | 7 days after outpatient treatment | |
Secondary | SF-36 at 30 days post-treatment | Compare SF-36 weighted sums (0-100 scale; lower score means more disability) in patients between Intervention & Control groups | 30 days after outpatient treatment | |
Secondary | SF-36 at 60 days post-treatment | Compare SF-36 weighted sums (0-100 scale; lower score means more disability) in patients between Intervention & Control groups | 60 days after outpatient treatment | |
Secondary | SF-36 at 90 days post-treatment | Compare SF-36 weighted sums (0-100 scale; lower score means more disability) in patients between Intervention & Control groups | 90 days after outpatient treatment | |
Secondary | Adverse events: bleeding incidents during Outpatient treatment | Compare number of Adverse Events (bleeding incidents) in patients between Intervention & Control groups: bleeding, line-related infection, etc. | Start of treatment to discharge, which is usually the same day, but up to 3 days post-treatment, if medically necessary. | |
Secondary | Adverse events: line infections during Outpatient treatment | Compare number of Adverse Events (line infections) in patients between Intervention & Control groups: bleeding, line-related infection, etc. | Start of treatment to up to 14 days post-treatment. | |
Secondary | Costs | Compare costs (dollars) between Intervention & Control groups | Baseline (Randomization) to 90 days post-discharge |
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