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Inorganic Nitrates in Intermediate High-risk Pulmonary Embolism

RecruitingNAAges 18 Years - anyAllKarolinska Institutet
NCT07431229 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pulmonary embolism (PE) is a serious condition caused by blood clots blocking the blood vessels in the lungs. In some patients, PE leads to increased pressure in the lung circulation and strain on the right side of the heart. Patients with intermediate high-risk PE have signs of right heart stress and heart muscle injury and are at risk of clinical deterioration despite standard treatment with anticoagulation. In addition to the mechanical obstruction caused by blood clots, pulmonary embolism also causes narrowing of the lung blood vessels due to vasoconstriction. This increases pulmonary vascular resistance and contributes to elevated pressure in the pulmonary arteries, which can worsen right heart function. Treatments that reduce pulmonary artery pressure and vascular resistance could therefore potentially improve heart function and stabilize patients in the acute phase of PE. However

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📋 Eligibility rules (as published)
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
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What it tests

  • nitrate-rich beetroot juice/placebo beetroot juice
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Where

2 sites
South hospital Stockholm
Stockholm, Sweden
Stockholm, Sweden
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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