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 >60years
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 (defined as creatinine > 30mg/g or 3mg/mmol whatever the gender)
• 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 NT-proBNP/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 (life limiting or less than 2 years remission)
• Autoimmune disease
• Hepatic Disease
2. Pre-existing diagnosis of clinical HF (including a history of HF hospitalization)
3. Moderate/severe LV systolic ventricular dysfunction, i.e. LVEF <45%
4. Moderate or severe valve disease (investigators opinion)
5. Corrected eGFR< 30ml/min/1.73m2, using the MDRD four-variable equation
6. Serum potassium >5.0 mmol/L and serum sodium <125 mmol/L (whether or not associated with hepatic cirrhosis)
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 or to any of its excipients.
11. Patients who require treatment with prohibited medications according to the summary of product characteristics with the exception of ACE inhibitors or angiotensin receptor blockers – although not their combination
12. Patients unable to give written informed consent.
13. Participation in another interventional trial in the preceding month
14. Ability to walk is, in the investigators opinion, clearly limited by joint disease or other locomotor problems or lung diseases rather than by cardiorespiratory fitness
15. Patient who have been admitted to an institution by an administrative or court order
16. Patient who are employed by the Sponsor, Investigator or the trial site

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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