NCT01807221|CompletedPhase 2ResultsDMC

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

ARTS-HF

A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone Versus Eplerenone

Bayer ClinicalTrials.gov

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2 other identifiers

145642012-002627-15

Study Type

interventional

Target

1,066

Locations

24 countries

Sites

168

Timeline

RegisteredMar 2013

StartedJun 2013

CompletionDec 2014

Brief Summary

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,066

participants targeted

Target at P75+ for phase_2 heart-failure

Timeline

Completed

Started Jun 2013

Geographic Reach

24 countries

168 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

March 7, 2013

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed

3 months until next milestone

Study Start

First participant enrolled

June 17, 2013

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2014

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2014

Completed

6.5 years until next milestone

Results Posted

Study results publicly available

June 15, 2021

Completed

Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

March 7, 2013

Results QC Date

April 15, 2021

Last Update Submit

July 2, 2021

Conditions

Heart Failure

Keywords

Heart Decompensation

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90
N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Baseline and Day 90

Secondary Outcomes (7)

Number of Participants With Death Due to Any Cause
Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Number of Participants With Cardiovascular Hospitalization
Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)
Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Ratio of BNP at Specified Visits to BNP at Baseline
Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline
Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
+2 more secondary outcomes

Other Outcomes (4)

Change From Baseline in Serum Potassium at Specified Visits
Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Change From Baseline in Systolic Blood Pressure at Specified Visits
Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Change From Baseline in Diastolic Blood Pressure at Specified Visits
Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
+1 more other outcomes

Study Arms (6)

Finerenone(BAY94-8862)[2.5mg] + Placebo

EXPERIMENTAL

Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.