Clinical trial NCT05840536: Combination Diuretic Therapy for Acute Decompensated Heart Failure
Official title: Efficacy and Tolerability of Combination Intravenous Diuretic Therapy Versus Intravenous Loop Diuretic Therapy Alone for the Treatment of Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Acute Decompensated Heart Failure
Keywords: heart failure
acute
diuretic
management
renal function
chlorothiazide
furosemide
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with heart failure are often admitted to the hospital because they have accumulated excessive amounts of fluid, they become short of breath and congested with fluid. Removing the excess fluid is necessary to improve the patients symptoms and reduce the risk of being re-admitted to the hospital. Diuretics ("water pills") are often given through an IV to accelerate the fluid removal. Furosemide is commonly used for fluid removal, however some patients do not respond well to the medication. There are other diuretics available that can work in conjunction with furosemide and increase the rate of fluid removal. The other "water pills" have slightly different mechanisms of action in the body compared to furosemide and when combined they may increase fluid removal.

The investigators hypothesize that adding chlorothiazide to furosemide will result in quicker and more effective fluid removal in heart failure patients.

Detailed description: The investigators will randomly assign patients to receive either furosemide alone or furosemide in combination with chlorothiazide when they are admitted to the hospital with acute heart failure and excessive volume.

All patients will be monitored for rate of fluid removal, improvement in symptoms, and side-effects of the medications.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Acute Decompensated Heart Failure - by at least 1 symptom (dyspnea, exercise intolerance, weight gain, edema) and at least 1 sign (chest x-ray (CXR), elevated brain natriuretic peptide (BNP), rales, elevated jugular venous pressure (JVP)).
* History of Congestion Heart Failure (CHF) with chronic loop diuretic use for at least the past 4 weeks
* Echocardiogram in the past 12 months (to document Ejection fraction (EF))

Exclusion Criteria:

* Chronic Kidney Disease (CKD) or Acute Kidney Injury (AKI) - Cr \>2.5 mg/dL
* Ventricular assist device
* Cardiogenic shock
* Need for mechanical or vasopressor support on admission
* Significant co-morbidities: Chronic Obstructive Pulmonary Disease, pneumonia, pulmonary embolism
* History of pulmonary hypertension (PAH) (World Health Organization (WHO) group I primary PAH)
* Acute Ischemia / post-intervention (Coronary Artery Bypass Graft, Percutaneous Coronary Interventions) in the past 90 days

Primary outcomes:
measure: Volume of Diuresis
timeFrame: During Index Hospitalization at 72 hours
measure: Change in Serum Creatinine from Baseline
timeFrame: During Index Admission up to 120 hours
Secondary outcomes:
measure: Hypokalemia
timeFrame: From date of index hospitalization until 72 hours after diuresis
measure: Electrolyte Disturbances
timeFrame: From date of index hospitalization until 72 hours after diuresis
measure: Total Weight Loss
timeFrame: From date of index hospitalization until 72 hours after diuresis
measure: Relief of Symptoms
timeFrame: From date of index hospitalization until 72 hours after diuresis
measure: Length of Stay
timeFrame: From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
measure: Potassium Replacement Requirements
timeFrame: From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
measure: Adverse Events
timeFrame: From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Heart and Vascular Institute
state: Louisiana
Study officials:
affiliation: Ochsner Heart and Vascular Institute
name: Patrick T Campbell, MD
role: STUDY_DIRECTOR
affiliation: Ochsner Heart and Vascular Institute
name: Stacy Mandras, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419.
citation: Channer KS, McLean KA, Lawson-Matthew P, Richardson M. Combination diuretic treatment in severe heart failure: a randomised controlled trial. Br Heart J. 1994 Feb;71(2):146-50. doi: 10.1136/hrt.71.2.146.
citation: Peacock WF, Costanzo MR, De Marco T, Lopatin M, Wynne J, Mills RM, Emerman CL; ADHERE Scientific Advisory Committee and Investigators. Impact of intravenous loop diuretics on outcomes of patients hospitalized with acute decompensated heart failure: insights from the ADHERE registry. Cardiology. 2009;113(1):12-9. doi: 10.1159/000164149. Epub 2008 Oct 17.