To demonstrate the superiority of finerenone to placebo in reducing the rate of the composite CV endpoint.To determine superiority of finerenone to placebo for each secondary endpointTo assess the safety and tolerability of finerenone
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine whether finerenone is superior to placebo in reducing the rate of
the composite CV endpoint.
Cardiovascular (CV) death and total (first and recurrent) HF events (HHF or
urgent HF visit) in HF patients (New York Heart Association [NYHA] class II-IV)
and LVEF >=40%.
Secondary outcome
•. Time to total (first and recurrent) HF events
• Improvement in NYHA class from Baseline to Month 12
• Change from baseline to Month 6, 9 and 12 in Total Symptom Score (TSS) of the
KCCQ.
• Time to first occurrence of composite renal endpoint: sustained decrease in
estimated glomerular filtration rate (eGFR) >=50% relative to baseline over at
least 4 weeks, or sustained eGFR decline <15ml/min/1.73m2 or initiation of
dialysis or renal transplantation.
• Time to all-cause mortality.
Background summary
A study to gather information on the influence of study drug finerenone on the
number of deaths and hospitalizations in participants with heart failure.
Study objective
To demonstrate the superiority of finerenone to placebo in reducing the rate of
the composite CV endpoint.
To determine superiority of finerenone to placebo for each secondary endpoint
To assess the safety and tolerability of finerenone
Study design
Multicenter, randomized, double-blind, parallel-group, placebo-controlled
study.
Intervention
Finerenone of placebo;
1. Participants with an eGFR <=60 mL/min/1.73m² starting dose 10 mg OD. Maximum
dose 20 mg and minimum dose 10 mg OD.
2. Participants with an eGFR >60 mL/min/1.73m² starting dose 20 mg OD. Maximum
dose 40 mg and minimum dose 10 mg OD.
Study burden and risks
More information on the safety as well as burden and risks is available in the
PIIC and the IB.
In addition there could be potential side effects or potential burden due to
the procedures done in this study.
In our opinion the impact on the patient is minimal. If they are perceived as
disadvantageous for the patient, the patient can always stop the study without
giving any reason and without experiencing any consequences for medical care.
Siriusdreef 36
Hoofddorp 2132 WT
NL
Siriusdreef 36
Hoofddorp 2132 WT
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-000306-29-NL |
| CCMO | NL73605.056.20 |