Heart Failure With Reduced Ejection FractionNCT05974566
Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction
An observational study of Heart Failure With Reduced Ejection Fraction and Diabetes Mellitus, run by Chongqing Medical University.
Trial summary
Finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (MRA), nowadays it's widely used in type 2 diabetes (T2DM) patients with chronic kidney disease (CKD), the newest trial shows finerenone improve the cardiovascular outcomes among patients with T2DM and CKD especially reduce the risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Diabetes Mellitus, Diabetic Nephropathies
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with heart failure with reduced ejection fraction and NYHA classes II-IV with or without diabetic nephropathy will be incorporated in the study, and other patients who are unable to tolerant treatment will be excluded
Who may be able to join
- Age ≥ 18 years
- New York Heart Association(NYHA) functional classification II - IV
- LVEF measured by the echocardiogram ≤ 45%
- eGFR>25mL/min/1.73m²
Who cannot join
- LVEF measured by the echocardiogram > 45%
- 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)
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Finerenone in Patients With Heart Failure With Reduced Ejection Fraction
Finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (MRA), nowadays it's widely used in type 2 diabetes (T2DM) patients with chronic kidney disease (CKD), the newest trial shows finerenone improve the cardiovascular outcomes among patients with T2DM and CKD especially reduce the risk of hospitalization for heart failure. In patients with diabetic nephropathy, finerenone resulted in lower risks of CKD progression and cardiovascular events. Finerenone shows great potential therapeutic effect in chronic heart failure (CHF) patients with or without T2DM and CKD compared to eplerenone, but there is still no real world study on finerenone in patients with heart failure with reduced ejection fraction (HFrEF) and it's unclear about the effect of finerenone in CHF patients without T2DM and CKD. The investigators will conduct a study to demonstrate the efficacy and safety of finerenone in HFrEF patients compared to other MRAs.
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFrEF patients who accept finerenone therapy | Patients with HFrEF receive finerenone 10mg or 20mg daily treatment for 3 months in addition to other medications. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)
The change in serum NT-proBNP levels in patients was measured before medication and after 6 months of medication to determine the improvement on heart failure
Measured: before and after 6 months of medication
Secondary outcomes (4)
Composite endpoint of death and heart failure rehospitalization
The composite endpoint include the death due to cardiovascular reasons, worsening of renal disease, rehospitalization due to heart failure and admission to hospital to accept intravenous diuretics therapy
Measured: during the 6-month period of medication therapy
Change in left ventricular ejection fraction (LVEF)
The change in LVEF measured by echocardiogram
Measured: before and after 6 months of medication
Change in extracellular volume (ECV)
Extracellular volume (ECV) measured by cardiac magnetic resonance imaging (CMR) helps to demonstrate the improvement in myocardial fibrosis
Measured: Before and after 3 months of continuous treatment
Change in renal function level
Change in estimated glomerular filtration rate(eGFR) reflect the renal function
Measured: Before and after 3 months of continuous treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
- Investigators
- Dongying Zhang, PhD, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974566
- Sponsor's protocol ID
- 2023-07
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34449181Bakris 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.
PubMed 33264825Filippatos 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.
PubMed 27130705
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Finerenone in Patients With Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT05974566
- Acronym / sponsor ID
- 2023-07
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (MRA), nowadays it's widely used in type 2 diabetes (T2DM) patients with chronic kidney disease (CKD), the newest trial shows finerenone improve the cardiovascular outcomes among patients with T2DM and CKD especially reduce the risk of hospitalization for heart failure. In patients with diabetic nephropathy, finerenone resulted in lower risks of CKD progression and cardiovascular events. Finerenone shows great potential therapeutic effect in chronic heart failure (CHF) patients with or without T2DM and CKD compared to eplerenone, but there is still no real world study on finerenone in patients with heart failure with reduced ejection fraction (HFrEF) and it's unclear about the effect of finerenone in CHF patients without T2DM and CKD. The investigators will conduct a study to demonstrate the efficacy and safety of finerenone in HFrEF patients compared to other MRAs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFrEF patients who accept finerenone therapy | – | –Patients with HFrEF receive finerenone 10mg or 20mg daily treatment for 3 months in addition to other medications. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with heart failure with reduced ejection fraction and NYHA classes II-IV with or without diabetic nephropathy will be incorporated in the study, and other patients who are unable to tolerant treatment will be excluded
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- New York Heart Association(NYHA) functional classification II - IV
- LVEF measured by the echocardiogram ≤ 45%
- eGFR>25mL/min/1.73m²
Key exclusion criteria (13 listed)
- LVEF measured by the echocardiogram > 45%
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: before and after 6 months of medication
The change in serum NT-proBNP levels in patients was measured before medication and after 6 months of medication to determine the improvement on heart failure
4 secondary outcomes
Composite endpoint of death and heart failure rehospitalization
Time frame: during the 6-month period of medication therapy
Change in left ventricular ejection fraction (LVEF)
Time frame: before and after 6 months of medication
Change in extracellular volume (ECV)
Time frame: Before and after 3 months of continuous treatment
Change in renal function level
Time frame: Before and after 3 months of continuous treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Results publication: PubMed 34449181Pitt 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.
- Results publication: PubMed 33264825Bakris 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.
- Results publication: PubMed 27130705Filippatos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongying Zhang, PhD study chair
First Affiliated Hospital of Chongqing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction and Diabetes Mellitus, run by Chongqing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongying Zhang, PhD (+86-13608398395, zdy.chris@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) (time frame: before and after 6 months of medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05974566, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.