2024-519631-42-00Not yet recruitingPhase 4
LEVOMEMS: Comparison of the effects of dobutamine and levosimendan in the current treatment of heart diseases.
LEVOMEMS: Comparison of the Hemodynamic Profile of Dobutamine and Levosimendan in the Current Therapeutic Context
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To assess the change in the pulmonary arterial pressure and the cardiac output with levosimendan or dobutamine
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 20 Nov 2024
- Start date
- 14 Feb 2023
- Lead sponsor
- Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol
- Diseases
- Heart failure
- EU CT number
- 2024-519631-42-00
- EudraCT number
- 2022-002688-31
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 10
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure and a weak pumping heart. It compares how dobutamine and levosimendan change lung artery pressure and the amount of blood the heart pumps.
- Age
- Over 18 years
- Sex
- All
- Disease stage
- Heart failure with a left ventricular ejection fraction (FEVI) under 35% on an echocardiogram in the last 6 months. NYHA class above III, with limited function despite optimized heart failure and diuretic treatment. A hospital stay or decompensation treated as an outpatient with a diuretic in the last six months, which led to the CardioMEMS device.
- Earlier treatment
- Optimized heart failure treatment and a diuretic, as above.
Main reasons for not taking part
- Creatinine clearance under 20 ml / min
- Systolic blood pressure under 90 mmHg
- Women who can have children without effective contraception, or who are breastfeeding
- Pregnancy
- Hypersensitivity to the active ingredients or any excipient
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hypersensitivity to the active ingredients or to any of the excipients
Lab values
- Creatinine clearance <20 ml / min
Other
- Presión arterial sistólica <90 mmHg
- Pregnant or fertile women (who are in the period between menorrhagia and menopause) without effective contraceptive coverage, or in breastfeeding
Who the study is looking for
- Age> 18 years
- FEVI <35% for echocardiography in the last 6 months
- Functional class NYHA> III with functional impairment despite optimized treatment of HF and diuretic with admission or decompensation treated on an outpatient basis with diuretic in the last six months that motivate the implementation of the CardioMEMS device
- Signing of informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.