Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study

NCT07523867 | Not Yet Recruiting Phase 4

• 1 other identifier: HM-IC-SAFEK
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the safety of finerenone compared with alternate-day spironolactone in patients with heart failure and diabetic kidney disease at increased risk of hyperkalemia. Patients with chronic kidney disease and heart failure often benefit from mineralocorticoid receptor antagonists, but their use is frequently limited by elevated potassium levels. Finerenone has been associated with a lower risk of hyperkalemia in clinical trials, but direct comparisons with spironolactone in high-risk patients are limited. In this randomized study, eligible participants will be assigned to receive either finerenone once daily or spironolactone on alternate days, in addition to standard therapy. Patients will be closely monitored during hospitalization and followed for 4 weeks. The primary outcome is clinically relevant hyperkalemia, defined by elevated potassium levels or the need to adjust or discontinue treatment due to hyperkalemia. Secondary outcomes include changes in potassium levels, kidney function, and clinical events. This study aims to provide practical evidence to guide the safe use of mineralocorticoid receptor antagonists in patients at high risk for hyperkalemia.

Conditions

Heart Failure; Diabetic Kidney Disease; Hyperkalemia

Keywords

Finerenone; Spironolactone; Heart Failure Treatment; Chronic Kidney Disease; Hyperkalemia; Mineralocorticoid Receptor Antagonist; Cardiorenal Syndrome

Outcome Measures

Primary Outcomes (1)

• Clinically Relevant Hyperkalemia

  Clinically relevant hyperkalemia is defined as the occurrence of any of the following: serum potassium ≥ 5.5 mEq/L, temporary or permanent discontinuation or dose adjustment of the study drug due to hyperkalemia, or need for potassium-lowering therapy.

  Up to 4 weeks after randomization

Secondary Outcomes (4)

• Change in Serum Potassium

  Baseline to 4 weeks

• Time to First Hyperkalemia Event

  Up to 4 weeks

• Temporary or Permanent Discontinuation of Study Drug

  Up to 4 weeks

• Change in Albuminuria and in Renal Function

  Up to 4 weeks.

Other Outcomes (2)

• Heart Failure Hospitalization

  Up to 4 weeks

• All-Cause Mortality

  Up to 4 weeks

Study Arms (2)

Finerenone

EXPERIMENTAL

Participants assigned to this arm will receive finerenone 10 mg orally once daily, in addition to standard of care therapy for heart failure and diabetic kidney disease.

Drug: Finerenone

Alternate-Day Spironolactone

ACTIVE COMPARATOR

Participants assigned to this arm will receive spironolactone 25 mg orally on alternate days, in addition to standard of care therapy for heart failure and diabetic kidney disease.

Drug: Spironolactone (drug)

Interventions

Finerenone DRUG

Finerenone 10 mg administered orally once daily. Treatment is given in addition to standard of care therapy for heart failure and diabetic kidney disease. Dose interruption or discontinuation may occur according to protocol-defined safety criteria, particularly in the setting of hyperkalemia.

Finerenone

Spironolactone (drug) DRUG

Spironolactone 25 mg administered orally on alternate days. Treatment is given in addition to standard of care therapy for heart failure and diabetic kidney disease. Dose interruption or discontinuation may occur according to protocol-defined safety criteria, particularly in the setting of hyperkalemia.

Alternate-Day Spironolactone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of heart failure, regardless of left ventricular ejection fraction
• Diagnosis of type 2 diabetes mellitus
• Diabetic kidney disease, defined by the presence of albuminuria (urinary albumin-to-creatinine ratio ≥ 30 mg/g)
• Estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m²
• Serum potassium between 5.0 and 5.5 mEq/L at screening
• Receiving or eligible to receive standard of care therapy for heart failure
• Ability to provide written informed consent
• Ability to comply with study procedures and follow-up visits

You may not qualify if:

• Serum potassium \> 5.5 mEq/L at screening
• Acute kidney injury at the time of enrollment
• Symptomatic hypotension or systolic blood pressure \< 90 mmHg
• Clinically significant arrhythmias requiring immediate intervention
• Known hypersensitivity or contraindication to finerenone or spironolactone
• Use of potassium-sparing diuretics other than the study drugs
• Pregnancy or breastfeeding
• Participation in another interventional clinical trial
• Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures

Sponsors & Collaborators

• Hospital de Messejana Dr. Carlos Alberto Studart Gomes: lead

MeSH Terms

Conditions

Heart Failure; Diabetic Nephropathies; Hyperkalemia; Renal Insufficiency, Chronic; Cardio-Renal Syndrome

Interventions

finerenone; Spironolactone; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Jefferson L Vieira, MD, PHD

CONTACT

+5585981236289; unidadepesquisaclinica@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label trial with blinded endpoint assessment (PROBE design). Participants and treating physicians are aware of treatment allocation, while outcome assessors and data analysts are blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior author

Model Details: Participants will be randomized in a 1:1 ratio to receive either finerenone once daily or spironolactone administered on alternate days, in addition to standard of care therapy. Participants will be followed for 4 weeks with intensive monitoring of serum potassium and renal function.

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04