Comparision of the effect on pulmonary pressure and other cardiac variables of levosimendan or dobutamin

LEVO-MEMS: COMPARISION OF THE HAEMODINAMIC PROFILE OF DOBUTAMIN AND LEVOSIMENDAN IN THE CURRENT THERAPEUTICAL CONTEXT

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002688-31-ES

Enrollment

Registered

2022-08-25

Start date

2023-01-25

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure patients with depressed left ventricular ejection fraction MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10010684 Term: Congestive heart failure System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10019284 Term: Heart failure, congestive System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 100241

Interventions

Trade Name: Dobutamina Product Name: dobutamina Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: Dobutamine CAS Number: 34368-04-2 Trade Nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age> 18 years 2. FEVI 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 4. Signing of informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: 1. Creatinine clearance <20 ml / min 2. Systolic blood pressure <90 mmHg 3. Pregnant or fertile women (who are in the period between menorrhagia and menopause) without effective contraceptive coverage, or in breastfeeding 4. Hypersensitivity to the active ingredients or to any of the excipients

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the change in the pulmonary arterial preassure and the cardiac output with levosimendan or dobutamin;Secondary Objective: Assess the hospital admisions and mortality, the changes in quality of life, changes in cardiac biomarkers (CA125, ST2, TnT, NTproBNP), changes in pulmonary echocardiography, changes in renal function and arterial hipotension.;Primary end point(s): Pulmonary blood pressure measured in mmhg and cardiac output measured in l / min;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: To assess the change in the pulmonary arterial preassure and the cardiac output with levosimendan or dobutamin;Secondary Objective: Assess the hospital admisions and mortality, the changes in quality of life, changes in cardiac biomarkers (CA125, ST2, TnT, NTproBNP), changes in pulmonary echocardiography, changes in renal function and arterial hipotension.;Primary end point(s): Pulmonary blood pressure measured in mmhg and cardiac output measured in l / min;Timepoint(s) of evaluation of this end point: 3 months

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Secondary

Measure	Time frame
Secondary end point(s): - Combined criteria for death or rehospitalization for heart failure at the beginning and end of each period. - Scores observed in the EuroQoL-5D quality of life test at the beginning and end of each period. - Scores observed in the 6-minute test at the beginning and end of each period. - CA125, ST2, TnT and NTProBNP levels at the beginning and end of each period. - Pulmonary congestion parameters by pulmonary ultrasound: B lines. - Renal function parameters:% of glomerular filtrate or creatinine levels (mg / dl), hypotension (systolic blood pressure <100mmHg). - Adverse events resulting from the administration of the drug;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Secondary end point(s): - Combined criteria for death or rehospitalization for heart failure at the beginning and end of each period. - Scores observed in the EuroQoL-5D quality of life test at the beginning and end of each period. - Scores observed in the 6-minute test at the beginning and end of each period. - CA125, ST2, TnT and NTProBNP levels at the beginning and end of each period. - Pulmonary congestion parameters by pulmonary ultrasound: B lines. - Renal function parameters:% of glomerular filtrate or creatinine levels (mg / dl), hypotension (systolic blood pressure <100mmHg). - Adverse events resulting from the administration of the drug;Timepoint(s) of evaluation of this end point: 3 months

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Countries

Spain

Contacts

Public ContactClinical Trials, Cardiology

Germans Trias i Pujol Health Research Institute

pgastelurrutia@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026