INTENSIFY: PractIcal daily effectiveNess and TolEraNce of Procoralan® in chronic SystolIc heart Failure in GermanY

Not Applicable

Completed

• Conditions: Chronic stable systolic heart insufficiency; Circulatory System; Heart failure

• Registration Number: ISRCTN12600624
• Lead Sponsor: Servier Deutschland GmbH (Germany)

Brief Summary

2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25160945

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-19
• Study Completion: 2012-12-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3570

Inclusion Criteria

1. Adult patients (male, female) with chronic systolic heart insufficiency
2. New York Heart Association (NYHA)-Class II-IV, with resting heart rate superior or equal to 75

Exclusion Criteria

1. Does not meet inclusion criteria
2. Investigators should follow the Summary of Product Specifications (SmPC) of Procoralan®, which include the following contraindications:
2.1. Hypersensitivity to the active substance or to any of the excipients
2.2. Resting heart rate below 60 beats per minute prior to treatment
2.3. Cardiogenic shock
2.4. Acute myocardial infarction
2.5. Severe hypotension (< 90/50 mmHg)
2.6. Severe hepatic insufficiency
2.7. Sick sinus syndrome
2.8. Sino-atrial block
2.9. Unstable or acute heart insufficiency
2.10. Pacemaker dependent
2.11. Unstable angina
2.12. Atrioventricular (AV) block of 3rd degree
2.13. Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), Human immunodeficiency virus (HIV) protease inhibitors (nelfinavir, ritonavir) and nefazodone
2.14. Pregnancy, lactation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Change in heart failure symptoms and left ventricular function<br> 2. Effects of therapy on quality of life assessed by EQ-5D<br> 3. Effects of therapy on resting heart rate<br> 4. Information about how Procoralan® SmPC and patients information are followed via standardised documentation of the dosage of Procoralan®, of comedications and concomitant diseases<br> 5. Analysis of general tolerability of Procoralan® under routine conditions via standardised adverse reactions documentation and standardised documentation of therapy discontinuation<br> 6. Analysis of unknown adverse drug reactions via standardised documentation<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures