Optimizing treatment for pulmonary edema and heart failure
Vasodilation or Loop-diuretics for Initial Treatment of Pulmonary Edema or Congestion Due to Acute Heart Failure - a Randomized Placebo-controlled Trial
This study is testing which treatment works best for people with acute heart failure and pulmonary edema by comparing a diuretic, a vasodilator, and a combination of both.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 4 sites (Copenhagen, Copenhagen and 3 other locations) |
| Trial ID | NCT05276219 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who present with acute onset or worsening dyspnea and signs of pulmonary congestion.
Not a fit: Patients who have received more than 40 mg of IV furosemide within the last three hours or those with ongoing severe arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to improved treatment protocols for patients suffering from acute pulmonary edema and heart failure.
How similar studies have performed: While the use of loop-diuretics is well-established, this specific comparison of treatment strategies in a hyperacute setting is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 40 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 this trial is running
Copenhagen, Copenhagen and 3 other locations
- Bispebjerg Hospital — Copenhagen, Copenhagen, Denmark (Recruiting)
- Hvidovre Hospital — Copenhagen, Copenhagen, Denmark (Recruiting)
- Nordsjællands Hospital — Hillerød, Denmark (Recruiting)
- Roskilde Hospital — Roskilde, Denmark (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.