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

INTENSIFY: PractIcal daily effectiveNess and TolEraNce of Procoralan® in chronic SystolIc heart Failure in GermanY: An observational prospective multicentre study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN12600624

Enrollment

3570

Registered

2012-06-19

Start date

2012-04-19

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic stable systolic heart insufficiency Circulatory System Heart failure

Interventions

Observational study to get information about therapy of chronic systolic heart insufficiency with Procoralan®

under daily routine practice by cardiologists, internists and general practitioners. The diagnosis of angina will be confirmed by trialists at baseline. After the baseline visit, ther

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026