NCT02452515: CHIARA MIA 1

A Single-blind, Multicenter Pilot Study to Investigate the Safety and Tolerability of a 14 Day Oral Treatment With Different Doses of the Chymase Inhibitor BAY1142524 in Comparison to Placebo in Clinically Stable Patients With Left-ventricular Dysfunction After Myocardial Infarction

Completed Phase 2 Last updated 5 November 2017

What this trial tests

Phase 2 trial testing BAY1142524 in Heart Failure in 49 participants. Completed in 1 March 2016.

Timeline

1 July 2015

Primary endpoint
1 January 2016

1 March 2016

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	49
Start date	1 July 2015
Primary completion	1 January 2016
Estimated completion	1 March 2016
Sites	10 locations across Denmark, Germany, Italy

Drugs / interventions tested

• BAY1142524 — full drug profile →
• BAY1142524 — full drug profile →
• BAY1142524 — full drug profile →
• BAY1142524 — full drug profile →
• Placebo

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Bayer — full company profile →

Who can join

Adults 40 to 79, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of participants with adverse events
  Time frame: Up to 20 days
• Number of participants with serious adverse events
  Time frame: Up to 20 days

Sponsor's own description

The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objectives are the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. BAY1142524 will be administered in a parallel group design using four doses (5, 10, 25 mg twice daily, and 50 mg once daily). Each dose group consists of 9 patients treated with verum and 3 patients treated with placebo.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Multifunctional Role of Chymase in Acute and Chronic Tissue Injury and Remodeling.
   Dell'Italia LJ, Collawn JF, Ferrario CM. · · 2018 · cited 82× · PMID 29348253 · DOI 10.1161/circresaha.117.310978
2. Intracrine angiotensin II functions originate from noncanonical pathways in the human heart.
   Ferrario CM, Ahmad S, Varagic J, Cheng CP, et al · · 2016 · cited 47× · PMID 27233763 · DOI 10.1152/ajpheart.00219.2016
3. Increased fibroblast chymase production mediates procollagen autophagic digestion in volume overload.
   Fu L, Wei CC, Powell PC, Bradley WE, et al · · 2016 · cited 26× · PMID 26807691 · DOI 10.1016/j.yjmcc.2016.01.019
4. Reduced Left Atrial Emptying Fraction and Chymase Activation in Pathophysiology of Primary Mitral Regurgitation.
   Butts B, Ahmed MI, Bajaj NS, Cox Powell P, et al · · 2020 · cited 15× · PMID 32140620 · DOI 10.1016/j.jacbts.2019.11.006