A pilot trial to improve the medical protection of the heart from injury due to reduced blood flow

Phase 1

• Conditions: ischemia reperfusion injury; MedDRA version: 14.1Level: LLTClassification code 10055224Term: Cardiac ischemiaSystem Organ Class: 100000004849; MedDRA version: 14.1Level: LLTClassification code 10023031Term: Ischemia coronary artery originSystem Organ Class: 100000004849; MedDRA version: 14.1Level: LLTClassification code 10023033Term: Ischemia myocardialSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000887-27-AT
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-19
• Study Completion: 2017-06-13
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

-Signed informed consent
-Men and women aged between 40 and 85 years (inclusive)
-Body mass index <35 kg/m2
-Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

-Known hypersensitivity to the study drug or any excipients of the drug formulation
-Treatment with another investigational drug within 3 weeks prior to screening
-History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
-Severe renal failure (glomerula filtration rate < 30ml/min)
-Moderately or severe impaired left ventricular function (ejection fraction < 40%)
-Moderately or severe impaired right ventricular function
-Systolic pulmonary pressure > 45mmHg
-Acute or recent (<7 days) myocardial infarction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified