Optimizing treatment for pulmonary edema and heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of three treatment strategies for pulmonary edema in patients experiencing acute heart failure: intravenous loop-diuretics (furosemide), vasodilation (nitrates), and a combination of both. The study will be conducted in a randomized, double-blinded, placebo-controlled manner, with patients receiving treatment within three hours of hospital admission. The primary objective is to determine which strategy provides superior outcomes in the first six hours of treatment. The trial will include patients with signs of congestion and will evaluate their response to the different treatment approaches.

Why it matters

Who can join: the full rules

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

Where it's running

• Bispebjerg Hospital
  Copenhagen, Copenhagen, Denmark Recruiting
• Herlev University Hospital
  Herlev, Denmark Recruiting
• Hvidovre Hospital
  Hvidovre, Denmark Recruiting
• Roskilde Hospital
  Roskilde, Denmark Recruiting
• Nordsjællands Hospital
  Hillerød, Denmark Active not recruiting

Study contacts

• Principal investigator: Johannes Grand, PhD — Hvidovre University Hospital
• Study coordinator: Johannes Grand, MD, Phd, MPH
• Email: johannes.grand@regionh.dk
• Phone: +4535452121

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Infusion of furosemide to see if a loading infusion helps remove fluid better in acute heart failure

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• Characterizing phenotypes of acute heart failure

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• Peripheral Venous Pressure–Guided Care in Heart Failure

  In people with congestive heart failure, this study tests whether daily peripheral venous pressure measurements, used to guide treatment, can shorten hospital stays and reduce readmissions compared with standard care.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.