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

Phase 1
Conditions
HEART FAILURE
MedDRA version: 9.1Level: HLGTClassification code 10019280Term: Heart failures
Registration Number
EUCTR2007-000763-18-IT
Lead Sponsor
OSPEDALE S. RAFFAELE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
10
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

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
Secondary Outcome Measures
NameTimeMethod
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