A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction >= 40% (LVEF >= 40%).
- Conditions
- heart failureheart's inability to pump efficiently10019280
- Registration Number
- NL-OMON52867
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 73
1. Participant (male or female) must be aged 40 years and older, at the time
of signing the informed consent.
2. Diagnosis of heart failure with NYHA class II-IV, ambulatory or hospitalized
primarily for heart failure.
3. On diuretic treatment for at least 30 days prior to randomization.
4. Documented LVEF of >=40% measured by any modality within the last 12 months.
5. Structural heart abnormalities based on any local imaging measurement within
the last 12 months, defined by at least one of the following findings: LAD
>=3.8cm, LAA >=20cm2, LAVI >30 mL/m2, LVMI >=115 g/m2 (*)/ 95 g/m2 (*), septal
thickness or posterior wall thickness >=1.1 cm.
6. NT-proBNP >=300 pg/mL (BNP >= 100 pg/mL) in SR and patient does not have an
ongoing diagnosis of paroxysmal atrial fibrillation or NT-proBNP >=900 pg/mL
(BNP >= 300 pg/mL) in AF or if patient has an ongoing diagnosis of paroxysmal
atrial fibrillation obtained at the following time:
- Within 90 days prior to randomization if patient had been hospitalized for HF
requiring initiation or change in HF therapy or if patient had an urgent visit
for HF requiring intravenous (IV) diuretic therapy, both within 90 days prior
to randomization
OR
- Within 30 days prior to randomization if patient has not been hospitalized
for HF nor had an urgent HF visit within the past 90 days.
7. Women of childbearing potential can only be included in the study if a
pregnancy test is negative at screening and baseline and if they agree to use
adequate contraception which is consistent with local regulations regarding the
methods for contraception for those participating in clinical trials.
1. eGFR < 25 mL/min/1.73 m² at either screening or randomization visit.
2. Serum/plasma potassium >5.0 mmol/L at either screening or randomization
visit.
3. Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days
prior to randomization
4. Myocardial infarction or any event which could have reduced the ejection
fraction within 90 days prior to randomization
5. Coronary artery bypass graft surgery in the 90 days prior to randomization
6. Percutaneous coronary intervention in the 30 days prior to randomization
7. Stroke or transient ischemic cerebral attack within 90 days prior to
randomization
8. Probable alternative cause of participants* HF symptoms that in the opinion
of the investigator primarily accounts for patient*s dyspnea such as
significant pulmonary disease, anemia or obesity. Specifically, patients with
the below are excluded:
- Severe pulmonary disease requiring home oxygen, or chronic oral steroid
therapy
- History of primary pulmonary arterial hypertension
- Hemoglobin < 10 g/dl*
- Valvular heart disease considered by the investigator to be clinically
significant
- BMI > 50 kg/m2 at screening
9. SBP >=160 mmHg if not on treatment with >=3 blood pressure lowering
medications or >=180 mmHg irrespective of treatments, on 2 consecutive
measurements at least 2-minute apart, at screening or at randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine whether finerenone is superior to placebo in reducing the rate of<br /><br>the composite CV endpoint.<br /><br>Cardiovascular (CV) death and total (first and recurrent) HF events (HHF or<br /><br>urgent HF visit) in HF patients (New York Heart Association [NYHA] class II-IV)<br /><br>and LVEF >=40%.</p><br>
- Secondary Outcome Measures
Name Time Method <p>•. Time to total (first and recurrent) HF events<br /><br>• Improvement in NYHA class from Baseline to Month 12<br /><br>• Change from baseline to Month 6, 9 and 12 in Total Symptom Score (TSS) of the<br /><br>KCCQ.<br /><br>• Time to first occurrence of composite renal endpoint: sustained decrease in<br /><br>estimated glomerular filtration rate (eGFR) >=50% relative to baseline over at<br /><br>least 4 weeks, or sustained eGFR decline <15ml/min/1.73m2 or initiation of<br /><br>dialysis or renal transplantation.<br /><br>• Time to all-cause mortality.</p><br>