SPIRonolactone In the Treatment of Heart Failure - A double-blind, randomized, placebo-controlled, parallel group, interventional phase III study to evaluate the efficacy and safety of spironolactone compared to placebo on the composite endpoint of recurrent heart failure hospitalizations and cardiovascular death in patients with heart failure with mid- range or preserved ejection fraction - SPIRIT*HF DZHK08 (SPIRonolactone In the Treatment of Heart Failure)

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•1\. Written informed consent
•2\. Male or female, age \>\= 50 years
•3\. Current symptoms of Heart Failure (NYHA \>\= II) on diuretic treatment (any)
•4\. Symptom(s) of HF \>\= 30 days prior to VR
•5\. Left ventricular ejection fraction \>\= 40 % at screening measured by
•echocardiography or
•MRI and evidence of structural/ functional abnormalities (at least one of the
•o LAVI \> 34 ml/m2
•o E/e\*mean \>\= 13
•o Mean e\* (septal and lateral) \< 9 cm/s

•1\. History of hyperkalemia (potassium level \>\= 5\.5 mmol/L) within the past two
•weeks before
•2\. Hyponatremia (sodium level \< 135 mmol/L) prior to randomization
•3\. Severe renal dysfunction, defined as an estimated glomerular filtration rate
•of less than 30
•mL/min/1\.73m2\) as calculated by the CKD EPI 2009 formula at VScr/VR or serum
•level \>\= 1,8 mg/dl (\> 160 µmol/ml)
•4\. History of anuria or acute renal failure (as defined by the KDIGO 2012
•criteria for AKI;
•see Appendix XVIII.3\) within the past two weeks before VR

Not specified