ACUTE CHANGES OF ENERGETIC SUBSTRATES ON MIOCARDIAL FUNCTION AND METABOLISM, IN PATIENTS WITH CRONIC HEART FAILURE ACITRIM - ND

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000763-18-IT

Enrollment

Registered

2007-04-10

Start date

2007-02-20

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

HEART FAILURE MedDRA version: 9.1 Level: HLGT Classification code 10019280 Term: Heart failures

Interventions

Trade Name: CLINOLEIC 20 Pharmaceutical Form: Solution for infusion Trade Name: EPARINA BMS Pharmaceutical Form: Solution for infusion Concentration unit: IU international unit(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: PATIENTS WITH CHRONIC CARDIAC FAILURE CLASS NYHA II-III WITH SYMPTOMS EVEN IF UNDER TREATMENT FROM AT LEAST 3 MONTHS WITH STABLE DOSE FROM AT LEAST 4 WEEKS;TREATMENT WITH BETA BLOCKERS OR ACE INHIBITORS STARTED FROM 3 MONTHS OR MORE;EJECTION FRACTION MORE OR EQUAL TO 40 PROVED BY TRANSTORACIC ECO 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: MIOCARDIAC STROKE OR INSTABLE ANGINA WITHIN 3 MONTHS BEFORE ENROLLMENT;ALCOOL ABUSE;CONGESTIVE CARDIAC HEART FAILURE;SEVERE ARITMIA;DISEASE IN COAGULATION;SEVERE RENAL INSUFFICIENCY;CARDIAC ISCHEMAI DURING ENFORCED TEST;DIABETE MELLITUS;ACTIVE NEOPLASTIC PROCESSES;ETC

Design outcomes

Primary

Measure	Time frame
Main Objective: TO EVALUATE THE CHANGES IN CARDIAC METABOLISM AND CARDIAC ENERGETIC PREFERENCES AFTER EXTERNAL ADMINISTRATION OF FATTY ACIDS,ACIPIMOX O TMZ ALONE OR PUT TOGETHER;Secondary Objective: TO EVALUATE THE CHANGES IN CARDIAC METABOLISM AND CARDIAC ENERGETIC PREFERENCES AFTER EXTERNAL ADMINISTRATION OF FATTY ACIDS,ACIPIMOX O TMZ ALONE OR PUT TOGETHER;Primary end point(s): TO EVALUATE THE CHANGES IN CARDIAC METABOLISM AND CARDIAC ENERGETIC PREFERENCES AFTER EXTERNAL ADMINISTRATION OF FATTY ACIDS,ACIPIMOX O TMZ ALONE OR PUT TOGETHER	—

Measure

Time frame

Main Objective: TO EVALUATE THE CHANGES IN CARDIAC METABOLISM AND CARDIAC ENERGETIC PREFERENCES AFTER EXTERNAL ADMINISTRATION OF FATTY ACIDS,ACIPIMOX O TMZ ALONE OR PUT TOGETHER;Secondary Objective: TO EVALUATE THE CHANGES IN CARDIAC METABOLISM AND CARDIAC ENERGETIC PREFERENCES AFTER EXTERNAL ADMINISTRATION OF FATTY ACIDS,ACIPIMOX O TMZ ALONE OR PUT TOGETHER;Primary end point(s): TO EVALUATE THE CHANGES IN CARDIAC METABOLISM AND CARDIAC ENERGETIC PREFERENCES AFTER EXTERNAL ADMINISTRATION OF FATTY ACIDS,ACIPIMOX O TMZ ALONE OR PUT TOGETHER

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Countries

Italy

Outcome results

None listed

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