HOMAGE Study. An European multicenter study in patients with heart failure risks under spironolactone

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1.Written informed consent will be obtained prior to any study
procedure;
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)
Or
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
• Cancer
• 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
enrolment.
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

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

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