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Heart failure emergency: which drug works best first?

NCT ID NCT05276219

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tests whether opening blood vessels (vasodilation) or removing fluid (diuretics) is better for treating sudden fluid buildup in the lungs from heart failure. About 1,100 adults with severe shortness of breath and low oxygen levels will receive one of three treatments in the emergency room. The goal is to see which approach keeps patients alive and out of the hospital longer over 30 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,041 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Age ≥ 18 years 2. Acute (within minutes to days) onset or worsening of subjective dyspnea\* 3. Systolic blood pressure ≥100 mmHg 4. Oxygen saturation \<94% or need of oxygen 5. Signs or suspicion of congestion (peripheral edema, rales, and/or clinical suspicion of congestion) \* * by the best assessment from a medical doctor. Inclusion must not wait on x-ray or other measures: patients suspected of pulmonary congestion should be included immediately. Exclusion criteria 1. More than 50 mg IV furosemide within the last three hours before randomization including prehospital treatment. 2. More than 3 hours from hospital-admission to randomization 3. Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \> 180 or \< 40 bpm. 4. Suspected severe infection or sepsis. Exclusion criteria are purposely liberal, so patients can be included in accordance with everyday clinical practice. However, a safety criterion will be implemented: If blood pressure drops below 90 mmHg in 2 measurements with 5 minutes apart and/or if urine production is below 50 ml after 1 hour, the intervention will be stopped, and patients can receive furosemide and nitrates freely. We purposely chose not to exclude patients with aortic stenosis, since observational studies did not find excess risk of given nitrates to patients with pulmonary edema and aortic stenosis

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure pulmonary edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute heart failure Congestive heart failure Pulmonary edema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bispebjerg Hospital

    RECRUITING

    Copenhagen, Copenhagen, 2000, Denmark

  • Herlev University Hospital

    RECRUITING

    Herlev, 2650, Denmark

  • Hvidovre Hospital

    RECRUITING

    Copenhagen, Copenhagen, 2650, Denmark

  • Nordsjællands Hospital

    ACTIVE_NOT_RECRUITING

    Hillerød, Denmark

  • Roskilde Hospital

    NOT_YET_RECRUITING

    Roskilde, Denmark

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