Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT02556450
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent will be obtained prior to any study procedure;
* Age \>60 years
* Clinical risk factors for developing heart failure, either:
1. Coronary artery disease (h/o myocardial infarction, angioplasty or coronary artery bypass) Or
2. 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)
* 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)
Exclusion Criteria:
* Recent wound healing/inflammation:
* Surgical procedure, coronary, cerebral or peripheral vascular events or infection in the prior 3 months
* Cancer
* Autoimmune disease
* Hepatic Disease
* Pre-existing diagnosis of clinical HF
* Moderate/severe LV systolic ventricular dysfunction, i.e. LVEF \<45%
* Moderate or severe valve disease (investigators opinion)
* eGFR\< 30ml/min
* Serum potassium \>5.0 mmol/L
* Treatment with an MRA or a loop diuretic (furosemide, bumetanide, ethacrynic acid or torasemide) in the previous three months
* Potassium supplements or potassium-sparing diuretic at time of enrolment.
* Atrial fibrillation within one month prior to inclusion (AF lasting \<60 seconds on ambulatory ECG monitoring is permitted)
•. History of hypersensitivity to spironolactone.
* Requiring treatment with prohibited medication according to SmPC with exception of ACE inhibitors or angiotensin receptor blockers
* Patients unable to give written informed consent.
* Participation in another interventional trial in the preceding month
* Ability to walk is, in the investigators opinion, clearly limited by joint disease or other locomotor problems rather than by cardiorespiratory fitness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02556450
Study Brief:
Protocol Section:
NCT02556450