Highly detailed measurements of metabolism in the heart muscle in patients with chronic heart failure.
- Conditions
- Chronic Heart FailureMedDRA version: 20.0Level: LLTClassification code 10007540Term: Cardiac disorder NOSSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-003533-15-DK
- Lead Sponsor
- Department of Cardiology, Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
Dilated Cardiomyopathy
> 18 years of age.
Diagnosis of Dilated Cardiomyopathy (DCM)
Left ventricular Ejection Fraction (LVEF) of 10 – 45 %
Adequate hematologic and organ function, i.e.
ANC at least 1.500/uL
Platelet count >100/uL
Se bilirubin <1.5 UNL
ASAT, ALAT and AP up to 2.5 x UNL
Se creatinine up to 1.5 x UNL or creatinine clearance at least 30 ml/min
INR and aPTT at most 1.5 x UNL, except for patients on AK treatment
Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study. Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device. If the partner is non fertile or the patient has no sexual activities, this is also accepted.
Danish speaking
Able and willing to comply after 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Not able or willing to receive heart failure therapy
Patients not willing to participate
Uncontrolled serious medical condition, such as uncontrolled heart
disease, uncontrolled diabetes, intestinal obstruction, uncontrolled
hypertension, or recent cerebral ischemia
Receiving more than 50% of taget dose of ACE-inhibitor and
betablockers before inclusion
Previous heart surgery including PCI
Estimated Glomerular Filtration Rate (eGFR) <30 mL/min
Diabetes Mellitus
Intolerance to Pyruvate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method