NCT07431229 Inorganic Nitrates in Intermediate High-risk Pulmonary Embolism
| NCT ID | NCT07431229 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Pulmonary Embolism (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-02-17 |
| Primary Completion | 2028-02-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2026-02-17 with a primary completion date of 2028-02-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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, there is limited clinical evidence regarding the safety and effectiveness of pulmonary vasodilator therapy in this patient group. Inorganic nitrates, found naturally in foods such as beetroot, are converted in the body to nitric oxide, a substance that relaxes blood vessels. Inorganic nitrates have been shown to lower blood pressure and improve pulmonary hemodynamics in other cardiovascular conditions, and are generally considered safe. Their effects in patients with intermediate high-risk pulmonary embolism have not previously been studied in a randomized controlled trial. The aim of this study is twofold: first, to describe invasive hemodynamic measurements in patients with intermediate high-risk pulmonary embolism using right heart catheterization; and second, to investigate the safety, feasibility, and physiological effects of treatment with oral inorganic nitrate compared with placebo. This is a multicenter, double-blind, randomized controlled trial conducted at two hospitals in Sweden. Adult patients with confirmed acute pulmonary embolism, right ventricular dilation, and elevated cardiac troponin levels will be included after providing informed consent. All patients will receive standard care, including anticoagulation therapy. In addition, all participants will undergo right heart catheterization to measure pressures and blood flow in the heart and lungs. Participants will be randomly assigned to receive either nitrate-rich beetroot juice or a placebo beetroot juice for five days. Neither the patients nor the treating clinicians or investigators will know which treatment is given. The primary outcome is mean pulmonary artery pressure measured three hours after administration of the study treatment. Secondary outcomes include additional hemodynamic measurements, blood biomarkers, and safety outcomes such as low blood pressure or need for vasopressor treatment. The results of this study will improve understanding of pulmonary hemodynamics in intermediate high-risk pulmonary embolism and help determine whether inorganic nitrate therapy is safe and has beneficial physiological effects in this patient population.
Eligibility 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
Contact & Investigator
Jacob M Hollenberg, Professor
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT07431229 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07431229 currently recruiting?
Yes, NCT07431229 is actively recruiting participants. Contact the research team at jacob.hollenberg@ki.se for enrollment information.
Where is the NCT07431229 trial being conducted?
This trial is being conducted at Stockholm, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT07431229 clinical trial?
NCT07431229 is sponsored by Karolinska Institutet. The principal investigator is Jacob M Hollenberg, Professor at Karolinska Institutet. The trial plans to enroll 36 participants.