EUCTR2015-000413-48-ITActive, not recruitingPhase 1
Bioprofiling response to mineralocorticoid receptor antagonists for the prevention of heart failure. A proof of concept clinical trial within the EU FP7 HOMAGE programme ¿ Heart OMics in AGing - HOMAGE
ACS BIOMARKER0 sites800 target enrollmentStarted: January 19, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Written informed consent will be obtained prior to any study
- •2. Age >60 years
- •3. Clinical risk factors for developing heart failure, either:
- •Coronary artery disease (h/o myocardial infarction, angioplasty or
- •coronary artery bypass)
- •B. At least two of the following:
- •Diabetes Mellitus requiring Hypoglycaemic Pharmacotherapy
- •Receiving pharmacological treatment for Hypertension
- •Microalbuminuria
- •Abnormal ECG (left ventricular hypertrophy, QRS >120msec,
- •abnormal Q-waves)
- •4. Biological risk: NT-pro-BNP values between 125 and 1,000 ng/L or
- •BNP values between 35 and 280 pg/ml (consistent with ESC guidelines
- •indicating risk of HF but helping to rule out prevalent HF or atrial
- •fibrillation which are associated with marked increases in NTproBNP/
- •BNP and should be investigated)
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 640
Exclusion Criteria
- •1. Recent wound healing/inflammation:
- •Surgical procedure, coronary, cerebral or peripheral vascular events
- •or infection in the prior 3 months
- •Autoimmune disease
- •Hepatic Disease
- •2. Pre-existing diagnosis of clinical HF
- •3. Moderate/severe LV systolic ventricular dysfunction, i.e. LVEF <45%
- •4. Moderate or severe valve disease (investigators opinion)
- •5. eGFR< 30ml/min
- •6. Serum potassium >5.0 mmol/L
- •7. Treatment with an MRA or a loop diuretic (furosemide, bumetanide,
- •ethacrynic acid or torasemide) in the previous three months
- •8. Potassium supplements or potassium-sparing diuretic at time of
- •9. Atrial fibrillation within one month prior to inclusion (AF lasting <60
- •seconds on ambulatory ECG monitoring is permitted)
- •10. History of hypersensitivity to spironolactone.
- •11. Patients unable to give written informed consent.
- •12. Participation in another interventional trial in the preceding month
- •13. Ability to walk is, in the investigators opinion, clearly limited by
- •joint disease or other locomotor problems rather than by
- •cardiorespiratory fitness
Investigators
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