Inorganic nitrates for intermediate high-risk pulmonary embolism
Official title: Inorganic Nitrates in Pulmonary Embolism With Hemodynamic Instability
Run by Karolinska Institutet · NCT07431229 · Data updated 2026-11-12
This test gives nitrate-rich beetroot juice to see if lowering lung artery pressure helps people with intermediate high‑risk pulmonary embolism who have signs of right‑heart strain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Stockholm and 1 other locations) |
| Status | Recruiting |
| Started | February 17, 2026 |
| Main results expected | February 25, 2028 |
| Study ends | February 25, 2028 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT07431229 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with acute pulmonary embolism within 14 days who are hemodynamically stable but have imaging evidence of RV dilation and elevated troponin (>45 pg/ml) are the intended candidates.
✕Probably not a fit
Patients who are hemodynamically unstable, have received thrombolysis or thrombectomy, have contraindications to right heart catheterization, are on nitrate therapy, are pregnant, or have a short expected lifespan are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with intermediate high‑risk pulmonary embolism who show right ventricular dilation and elevated troponin will receive either nitrate-rich beetroot juice or a matching placebo. Participants undergo right heart catheterization to obtain invasive hemodynamic measurements including pulmonary artery pressure and pulmonary vascular resistance. The study compares immediate and short-term hemodynamic effects between the nitrate and placebo groups to see if inorganic nitrates reduce RV afterload and improve cardiac output. Safety monitoring includes clinical status, biomarkers, and standard anticoagulation care.
Why it matters
Potential benefit: If successful, this approach could lower pulmonary artery pressures and improve right‑ventricular function, potentially reducing the risk of clinical deterioration in the acute phase of PE.
How similar studies have gone: This approach is relatively novel: preclinical data and small human studies suggest inorganic nitrates can lower pulmonary vascular resistance, but robust clinical evidence in intermediate‑high risk PE is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Acute PE with symptoms \< 14 days confirmed by computer tomography (CT) AND RV dilatation on CT or ECHO AND Troponin T \> 45 pg/ml Exclusion Criteria: Cardiac arrest with cardiopulmonary resuscitation, Thrombolysis or endovascular thrombectomy, \< 18 years of age, Pregnancy, INR \> 2,5 or platelet count \< 100, DAPT or OAK, Inability to give informed consent to the study, Contraindications for right heart catheterization: mechanical devices, endocarditis, GUCH-patients, Short expected lifespan \< 120 days / withdrawal of care, Imdur or other medications with nitrates, Daily usage of mouth wash prescribed by dentist or doctor
Where it's running
-
South hospital Stockholm
Stockholm, Sweden Recruiting -
Stockholm, Sweden
Stockholm, Sweden Not yet recruiting
Study contacts
- Principal investigator: Jacob M Hollenberg, Professor — Karolinska Institutet
- Study coordinator: Jacob M Hollenberg, Professor
- Email: jacob.hollenberg@ki.se
- Phone: (+46) 070-4133442
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.