Acute Decompensated Heart Failure Clinical Trial
— DIVERSION-HFOfficial title:
A Pilot Study to Investigate the Safety and Efficacy of a Novel Furosemide Regimen, Administered Subcutaneously for the Treatment of Fluid Overload and to Evaluate the Feasibility for Home Treatment
Verified date | March 2017 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a, prospective, single center, open-label, pilot study to evaluate the safety and efficacy of the subcutaneous administration of a novel furosemide formulation. The results of this pilot study will be reviewed to determine the safety of the subcutaneous treatment regimen and to evaluate patient selection criteria for possible at home treatment. The intent is to conduct a future follow on study looking at the feasibility of at home treatment of patients referred to a hospital for treatment of fluid overload.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 7, 2017 |
Est. primary completion date | March 7, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Female or male 18 years or older 2. History of heart failure >90-days 3. Presenting to the University of Michigan Health System because of evidence of fluid overload and recommended for admission or observation unit stay to receive intravenous (IV) furosemide therapy. 4. Estimated excess fluid weight of 10 lbs or more from euvolemic state. 5. Estimated jugular venous pressure (JVP) = 10 cm above the right atrium (RA). 6. Evidence of edema up to mid shin or higher 7. Agreeing to sign informed consent and HIPAA authorization 8. Daily dose of furosemide prescribed = 160 mg, or torsemide = 40 mg or bumetanide = 4 mg. Exclusion Criteria: 1. Pregnant females or women of child-bearing age who are not willing to use an adequate form of contraception 2. Chronic Obstructive Pulmonary Disease (COPD) moderate or worse: FEV1/FCV ratio <0.7 and FEV1 <60 percent predicted. 3. Rapid atrial fibrillation (AF) (HR >100b/min) 4. Hypoxia (resting O2 saturation <9%) 5. Hypotension (systolic blood pressure (SBP) BP < 90 mmHg) 6. Uncontrolled diabetes mellitus (DM) (admission glucose levels > 300 mg/dL) 7. Advanced renal disease (eGFR < 30mL/min/1.73m2) 8. Hypoalbuminemia (Albumin < 3.0 g/dL) 9. Acute coronary syndrome 10. Serum potassium (K+) <3.5 meq/L or using potassium supplements equivalent to > 80meq/day. 13. On experimental medication or currently participating in cardiovascular research study. 14. Urinary tract abnormality or disorder interfering with urination. 15. Allergy to the active and inactive ingredients of the study medication. 16. Inability to comply with study requirements 17. Dementia 18. Ongoing substance abuse |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
Todd M Koelling, MD | scPharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy endpoint: Urine output per 24 hours | Efficacy will be measured as the ability of the diuretic regimen given one or two times daily to achieve a net 24 hour urine output of 3000 cc or more over the first 24 hours of the study. | 24 hours | |
Primary | Safety endpoint: Composite of Severe hypokalemia, severe hyperkalemia, moderate to severe worsening of renal function, fever, sepsis, intravenous catheter infection, cardiac dysrhythmia causing syncope or requiring therapy or death | Safety will be assessed as the composite of developing any of the pre-specified serious adverse events: Severe hypokalemia, severe hyperkalemia, moderate to severe worsening of renal function, fever, sepsis, intravenous catheter infection, cardiac dysrhythmia causing syncope or requiring therapy, death. | 24 hours | |
Secondary | Functional Status | New York Heart Association class | 24 hours | |
Secondary | Quality of life | Kansas City Cardiomyopathy Questionnaire | 24 hours | |
Secondary | Congestion Scale | Change in congestion scale | 24 hours | |
Secondary | Breathlessness | Visual analog scale for dyspnea | 24 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04049045 -
Effects of Empagliflozin on Diuresis and Renal Function in Patients With Acute Decompensated Heart Failure
|
Phase 2 | |
Active, not recruiting |
NCT05100836 -
SURPASS Impella 5.5 Study
|
||
Recruiting |
NCT02898181 -
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
|
N/A | |
Completed |
NCT02823626 -
High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure
|
||
Completed |
NCT02248831 -
Evaluation of Cardiopulmonary Diseases by Ultrasound
|
N/A | |
Completed |
NCT02196038 -
A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
|
N/A | |
Completed |
NCT00693745 -
Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF
|
N/A | |
Not yet recruiting |
NCT04391231 -
HEMolysis in a Percutaneous Axial Flow LVAD, Effects of Pentoxifylline in a Randomized Controlled Trial
|
Phase 4 | |
Recruiting |
NCT05206422 -
DORAYA-HF Early Feasibility Study
|
N/A | |
Recruiting |
NCT01960218 -
Gas Exchange for Predicting Hospital Heart Failure Readmissions
|
N/A | |
Terminated |
NCT00904488 -
Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure
|
Phase 4 | |
Terminated |
NCT02620384 -
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)--A Single Center Pilot Study.
|
Phase 3 | |
Completed |
NCT04318093 -
Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
|
Phase 2 | |
Recruiting |
NCT06161649 -
Mobile Education System to Improve Disease Knowledge, Self-efficacy and Quality of Life in Patients With Heart Failure
|
N/A | |
Completed |
NCT02289508 -
Role of USCOM in Adult Patients With Heart Failure
|
N/A | |
Terminated |
NCT01457053 -
Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics
|
N/A | |
Completed |
NCT04877652 -
DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics
|
||
Completed |
NCT03505788 -
Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR)
|
Phase 4 | |
Completed |
NCT03146754 -
A Study to Evaluate Lung Ultrasound as a Method to Measure Changes in Extravascular Lung Water Induced by Positional Changes (LUPE)
|
N/A | |
Terminated |
NCT05346653 -
The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure
|
Phase 4 |