European University hospital started a clinical trial of Spironolactone In The Treatment of Heart Failure
Charite University, Berlin, Germany is starting a new clinical trial of Spironolactone In The Treatment of Heart Failure.
The purpose of this study is to determine whether the treatment of patients with HFmrEF and HFpEF at high risk of cardiovascular events with the mineralocorticoid receptor antagonist (MRA) spironolactone reduces a composite of recurrent heart failure hospitalizations and cardiovascular mortality.
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- Male or female, age ≥ 50 years
- Current symptoms of Heart Failure (NYHA ≥ II) during VR
- Symptom(s) of HF ≥ 30 days prior to VR
- HF Hospitalization or treatment with intravenous (IV) diuretics for worsening HF within 12 months prior to VR
- Left ventricular ejection fraction ≥ 40 % at screening measured by echocardiography and evidence of structural/ functional abnormalities (at least one of the following criteria): LAVI > 34 ml/m2// E/émean ≥ 13// Mean e' (septal and lateral) < 9 cm/s
- NT-proBNP > 300 pg/ml (SR) or > 900 pg/ml (AF) on the Visit 1 ECG; only if NT-proBNP is NOT available: BNP > 80/ 250 pg/ml (SR/AF)
- Controlled systolic BP: defined as a target systolic BP < 140 mm Hg. Subjects with BP up to and including 160 mm Hg are eligible for enrollment if on 3 or more medications to control BP (Patients with uncontrolled BP should be considered for Re-Screening after optimization of antihypertensive therapy has been established)
- Serum potassium < 5.0 mmol/L prior to randomization.
The Charité – Universitätsmedizin Berlin is one of Europe's largest university hospitals, affiliated with Humboldt University and Free University Berlin. With numerous Collaborative Research Centres (CRC) of the Deutsche Forschungsgemeinschaft it is one of Germany's most research-intensive medical institutions. From 2012 to 2020, it was ranked by Focus as the best of over 1000 hospitals in Germany.
The contacts and locations are the Hospital of St. John of God, Eisenstadt, Austria; Medical University of Graz, Graz, Austria; Medical University Innsbruck, Innsbruck, Austria; Clinic Klagenfurt Wörthersee, Klagenfurt, Austria; Bremer Institute for Heart and Circulation Research at the Klinikum Links der Wese, Bremen, Germany; Heart Center Dresden, Technical University of Dresden, Dresden, Germany; University Hospital of Giessen, Gießen, Germany; University of Goettingen, Goettigen, Germany; Clinical Hospital Center B. Kosa, Belgrade, Serbia; Clinical Hospital Center Dr. Dragisa Misovic, Belgrade, Serbia.
The full list can be viewed at the link below.
For more details: https://ichgcp.net/clinical-trials-registry/NCT04727073
