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

Phase 1

• Conditions: Elderly patients with Clinical and Biological risk factors for developing heart failure; MedDRA version: 18.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-000413-48-NL
• Lead Sponsor: ACS Biomarker

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-19
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

1.Written informed consent will be obtained prior to any study procedure;
2. Age >65years
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 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) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

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