OUTpatient Intravenous LASix Trial in Reducing Hospitalization for Acute Decompensated Heart Failure

NCT04691687 | Completed Phase 4 FDA Drug

• 1 other identifier: 307139
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single-center, prospective double-blinded randomized control trial to evaluate the the feasibility, efficacy and safety of outpatient IV diuretic therapy in treatment of heart failure.

Conditions

Heart Failure

Keywords

heart failure; hospitalization; diuretics; IV diuretics; mortality

Outcome Measures

Primary Outcomes (1)

• Re-hospitalization for Heart Failure

  30-day rehospitalization for Heart Failure

  30 days

Secondary Outcomes (3)

• Kansas City Cardiomyopathy Questionnaire(KCCQ) outcome measures

  Change from Baseline to 30 days

• Death, Myocardial Infarction, Stroke

  30 days, 180 days

• PHQ-2 outcome measures

  Change from Baseline to 30 days

Other Outcomes (2)

• New York Heart Association (NYHA) Class

  Baseline and 30 days

• LV function

  Baseline and 30 days

Study Arms (3)

Standard of Care (Group 1)

NO INTERVENTION

Patients in Group 1 received standard of care treatment per heart failure guidelines at the discretion of the primary cardiologist involved in the patient's care.

IV Placebo Infusion

PLACEBO COMPARATOR

Patients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake.The infusions were continuous over 3 hours, biweekly over a one-month period.

Drug: IV Solution

IV Furosemide Infusion

EXPERIMENTAL

The dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period.Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, SBP \<80 mmHg or symptoms of presyncope).

Drug: Furosemide

Interventions

Furosemide DRUG

IV loop diuretic therapy

Also known as: IV Furosemide

IV Furosemide Infusion

IV Solution DRUG

IV Placebo comparator

Also known as: IV Normal Saline 0.9%

IV Placebo Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients being admitted with ADHF over 18 years old
• Known history of systolic or diastolic dysfunction of greater than 6 weeks
• NYHA Class II-IV
• Heart failure as defined in \[Table 1\]. One symptom must be present at time of screening and one sign must be present in the last 12 months
• Elevated pro-BNP \>/= 360 pg/ml and not explained by any other etiology
• Willing to consent and comply with scheduled visits and phone calls
• Table 1. Criteria for Diagnosing Heart Failure
• SYMPTOMS (at least 1 must be present at time of screening):
• Paroxysmal nocturnal dyspnea
• Orthopnea
• Dyspnea on mild or moderate exertion
• SIGNS (at least 1 must be present in the last 12 months)
• Any rales post cough
• Jugular venous pressure \>/= 10 cm H20
• Lower extremity edema

You may not qualify if:

• Systolic blood pressure \<85 mmHg
• Signs of significant respiratory distress, according to the discretion of the investigator.
• Biventricular Implantable Cardioverter-Defibrillator(ICD) placement within 15 days, cardiogenic shock or volume depletion
• Chronic dialysis
• Acute renal failure defined as creatinine \> 2 x baseline
• Severe systemic illness with life expectancy judged less than three years
• Chronic pulmonary disease requiring home O2, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator
• Primary hemodynamically significant uncorrected valvular heart disease, obstructive, or regurgitant, or any valvular disease expected to lead to surgery during the trial.
• Atrial fibrillation with resting heart rate \>90 bpm
• Myocardial infarction in past 90 days
• Percutaneous coronary intervention in past 30 days
• Heart transplant recipient or currently implanted left ventricular assist device
• Stroke in past 90 days
• No acute infection especially requiring IV antibiotics
• Allergy to Lasix

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide; Infusions, Intravenous

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, nurses and treating physicians will be blinded to whether the subjects are receiving continuous IV furosemide (group 2) or continuous IV placebo (group 3). The pharmacist will not be blinded to help administer the appropriate medication. Because the trial will be double-blinded, safety laboratory tests will be performed for each subject for the duration of the trial, regardless of the treatment arm, and will be monitored by the research coordinator. Similarly, monitoring of potential side effects will be continuous and irrespective of treatment assignment. Outcomes assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of Cardiovascular Research

Model Details: A single center prospective randomized double-blind controlled trial

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 31, 2020
• Study Start: May 1, 2012
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share