Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Denmark / NCT03984591
Enrolling by invitation Phase 4

A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure

NCT03984591 · tracked via the Priya Life Science Denmark tracker
Sponsor
Bispebjerg Hospital
Phase
Phase 4
Started
2020-11-01
Last updated
2023-02-01

Condition(s) studied

Systolic Heart Failure

Investigational drug(s) / intervention(s)

Eplerenone →Spironolactone →

Eplerenone: Eplerenone according to guidelines

Spironolactone: Spironolactone according to guidelines

Study summary

Objective The objective is to compare the efficacy of spironolactone and eplerenone on clinical outcome in patients with heart failure and a reduced ejection fraction.

Method The study is a crossover cluster randomized trial. Each heart failure clinic in Denmark will be allocated to four periods (clusters): two periods with spironolactone and two periods with eplerenone as first drug. The planned total participation time for each department is 4 years and we estimate that data from 7200 patients will be accrued in this period. Endpoints will be assessed through Danish National Registries.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * all patients registered in the Danish Heart Failure Registry who has a baseline left ventricular ejection fraction \<40% and who has filled in a prescription for an aldosterone antagonist Exclusion Criteria: * patients who had filled in a prescription for an aldosterone antagonist prior ro registration in the Danish Heart Failure Registry

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Bispebjerg Hospital Copenhagen Denmark

On this site

📄 Aldactone (spironolactone) drug profile →

More Bispebjerg Hospital trials in Denmark

Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg? Recruiting
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery Starting soon
The InterVitaminK Trial - Effects of Vitamin K Supplementation on Cardiovascular, Metabolic, and Bone Health Active, not recruiting
Twenty-year Follow-up of the Inter99 Cohort Enrolling by invitation
Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03984591 on ClinicalTrials.gov ↗ ← All trials in Denmark