Health TrialsbyHealthPanel

Finerenone and Cardiac Remodeling in HFpEF

ConditionHeart Failure With Preserved Ejection Fraction
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

This prospective randomized study aims to evaluate the efficacy of Finerenone as add-on therapy to standard of care compared to standard of care alone in preventing heart failure worsening and preserving cardiac function assessed by left ventricular strain in patients with heart failure with preserved ejection fraction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than or equal to 18 years

Clinically evidenced heart failure with left ventricular ejection fraction greater than or equal to 50 percent

HFA-PEFF score greater than or equal to 5 or score 2 to 4 with functional testing confirming HFpEF

Sinus rhythm on resting ECG at screening

Disqualifiers

Implanted cardiac pacemaker or defibrillator with active atrial pacing

Estimated glomerular filtration rate less than 25 milliliters per minute per 1.73 square meters

Baseline serum potassium greater than 5 milliequivalents per liter

Known hypersensitivity to Finerenone

Trial design

Design model

Parallel

Treatments tested in this trial

  • Finerenone

    Drug

    Non-steroidal mineralocorticoid receptor antagonist 10 to 20 mg orally once daily for 6 months with monitoring of potassium creatinine and eGFR

  • Standard of care for HFpEF Description:

    Other intervention

    Standard of care for heart failure with preserved ejection fraction according to 2022 AHA ACC HFSA guideline including diuretics and guideline-directed medical therapy without Finerenone

Treatment groups

194 Participants
are divided into 2 treatment groups
Group A: Finerenone plus Standard of CareExperimental treatment 2 interventions
Group B: Standard of Care aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in left ventricular global longitudinal strain

Absolute change in left ventricular global longitudinal strain measured by speckle tracking echocardiography using QLAB 10.4 software from apical four-chamber views with three consecutive heart cycles greater than 61 frames per second. More negative values indicate better function

Time frame
From baseline to 6 months

Secondary outcomes

1

Change in left ventricular reservoir strain

Absolute change in left ventricular reservoir strain measured by speckle tracking echocardiography from baseline to 6 months

Time frame
From baseline to 6 months
2

Number of participants with heart failure hospitalization

Number of participants who experience heart failure hospitalization

Time frame
Up to 6 months
3

Number of participants with major adverse cardiovascular events

Number of participants with non-fatal myocardial infarction or ischemic stroke

Time frame
Up to 6 months
4

Change in NT-proBNP level

Change in N-terminal pro B-type natriuretic peptide level in picograms per milliliter

Time frame
From baseline to 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: