Authorised Therapeutic use (Phase IV) Acute heart failure with pulmonary congestion

VASODILATATION OR LOOP-DIURETICS FOR INITIAL TREATMENT OF PULMONARY CONGESTION DUE TO ACUTE HEART FAILURE – A RANDOMIZED PLACEBO-CONTROLLED TRIAL

EU CTIS ID: 2022-500035-36-01

What this study is testing

The main objective of this trial is to determine the superior strategy regarding emergency treatment (starting within 3 hours after hospital-admission) of pulmonary edema. The strategies are: 1. Loop-diuretics (Furosemide), 2. Vasodilation (nitrates), 3. A combination of both furosemide and nitrates. Patient-outcome will be evaluated through the primary endpoint as described elsewhere.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age ≥ 18 years
  • Acute (within minutes to days) onset or worsening of subjective dyspnea
  • Systolic blood pressure ≥100 mmHg
  • Oxygen saturation <94% or need of oxygen
  • Clinical signs or suspicion of congestion (peripheral edema, rales, and/or clinical suspicion of congestion)

You likely can't join if

  • More than 50 mg IV furosemide within the last three hours before randomization including prehospital treatment.
  • More than 3 hours from hospital-admission to randomization.
  • Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR > 180 or < 40 bpm.
  • Suspected severe infection or sepsis.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.