Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction
NCT ID: NCT05974566
Last Updated: 2023-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2023-08-01
2023-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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HFrEF patients who accept finerenone therapy
Patients with HFrEF receive finerenone 10mg or 20mg daily treatment for 3 months in addition to other medications.
No interventions assigned to this group
HFrEF patients who accept Spironolactone or eplerenone therapy
Patients with HFrEF receive spironolactone or eplerenone treatment daily treatment for 3 months in addition to other medications.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* New York Heart Association(NYHA) functional classification II - IV
* LVEF measured by the echocardiogram ≤ 45%
* eGFR\>25mL/min/1.73m²
Exclusion Criteria
* History of allergic or hypersensitivity to drugs involved in the trial.
* Patients with a known history of cancer, angioedema, significant congenital heart disease or rheumatic heart disease.
* Patients diagnosed with myocarditis.
* Probable alternative diagnoses could account for the patient's HF symptoms e.g., COPD, bronchial asthma, primary pulmonary hypertension.
* Systolic blood pressure (SBP) ≥180mmHg or diastolic blood pressure (DBP)
* 120mmHg at visit, DBP≤90mmHg or symptomatic hypotension.
* Patients with cardiac pacemaker
* Pregnant woman
* eGFR≤25mL/min/1.73m² and not accept long-term hemodialysis therapy.
* Serum potassium \>5.2 mmol/l at visit
* Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate\>150 bpm in AF patients.
* Obvious stenosis (≥50%) of bilateral renal arteries.
18 Years
ALL
No
Sponsors
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Chongqing Medical University
OTHER
Responsible Party
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Dongying Zhang
Director
Principal Investigators
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Dongying Zhang, PhD
Role: STUDY_CHAIR
First Affiliated Hospital of Chongqing Medical University
Central Contacts
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References
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Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.
Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.
Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.
Other Identifiers
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2023-07
Identifier Type: -
Identifier Source: org_study_id
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