Optimized Treatment of Pulmonary Edema or Congestion

Summary

Background:

Intravenous (IV) loop-diuretics have been a key component in treating pulmonary edema since the nineteen sixties and has a Class 1 recommendation in the 2021 European Society of Cardiology guidelines for heart failure. Conversely, vasodilation was downgraded in the treatment of acute heart failure due to a lack of trials that compare vasodilation with loop-diuretics in a hyperacute clinical setting. This clinical equipoise will be tested in a trial including patients with pulmonary congestion immediately at hospital admission.

Primary objective:

To determine the superior strategy of loop-diuretics (furosemide), vasodilation (nitrates) or the combination during emergency treatment.

Design: Investigator-initiated, randomized, double-blinded, placebo-controlled trial with 1:1:1 allocation.

Intervention:

Intervention-phase will last 6 hours from study-inclusion, and patients will be allocated to one of three groups:

* Boluses of 40 mg IV furosemide + nitrate-placebo as soon as possible and repeated up to 10 times.
* Boluses of 3 mg IV isosorbide dinitrate + furosemide-placebo as soon as possible.
* Boluses of both 3 mg IV isosorbide dinitrate + of 40 mg as soon as possible.

Conditions

• Pulmonary Edema
• Congestive Heart Failure
• Acute Heart Failure

Interventions

DRUG

Furosemide and isosorbide dinitrate

Vasodilation (iv isosorbide dinitrate) strategy for decongestion in acute heart failure AND A diuretic (iv furosemide) strategy for decongestion in acute heart failure

DRUG

Furosemide Injection

A diuretic (iv furosemide) strategy for decongestion in acute heart failure

DRUG

Isosorbide Dinitrate

Vasodilation (iv isosorbide dinitrate) strategy for decongestion in acute heart failure

Sponsors & Collaborators

• Zealand University Hospital

  collaborator OTHER

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Johannes Grand, PhD · Hvidovre University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-14

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• Denmark

Study Locations