A phase II trial to study neladenoson bialanate over 20 weeks in patients with chronic heart failure with reduced ejection fractio

Phase 1

• Conditions: chronic heart failure with reduced ejection fraction (LVEF equal or below 35%); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003839-38-BE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-22
• Last Update Posted: 25 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

1. Men or women aged 18 years and older
2. Diagnosis of chronic heart failure (CHF), NYHA class II-IV, LVEF = 35% assessed by any imaging modality (e.g. echocardiography, cardiac magnetic resonance [CMR], cine levocardiography) within 6 months prior to run-in: if several values are available the last assessment of EF should be = 35%.
3. One of the following (or both),
a) Worsening CHF requiring hospitalization or an unscheduled outpatient visit in the last 3 months, both requiring initiation or intensification of heart failure therapy and with either:
o BNP = 100 pg/mL or NT-proBNP =400 pg/mL (sinus rhythm) or
o BNP = 300 pg/mL or NT-proBNP =1200 pg/mL (atrial fibrillation)
AND/OR
b) at any time in the past 4 weeks one of:
o BNP = 300 pg/mL or NT-proBNP = 1200 pg/mL (sinus rhythm)
o BNP = 600 pg/mL or NT-proBNP = 2400 pg/mL (atrial fibrillation)
For patients on treatment with angiotensin receptor-neprilysin inhibitors (ARNIs), e.g. Entresto only NT-proBNP values can be used to assess eligibility.
4. Written informed consent before any study-specific procedure

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 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 288

Exclusion Criteria

1. Acute de-novo heart failure
2. Requirement of any of the following 48 hours prior to randomization: IV vasodilating drugs (e.g. nitrates, nitroprusside)
- IV natriuretic peptides (e.g. nesiritide, carperitide) - IV positive inotropic agents - IV diuretics - IV antibiotics - Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
3. Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy
4. Patient with known clinically significant persistent coronary ischemia based on medical history, preexisting or current exercise testing
5. Occurrence of any of the following within 3 months prior to randomization:
o Myocardial infarction
o Hospitalization for unstable angina
o Stroke or TIA
o Coronary artery bypass graft (CABG)
o Percutaneous coronary intervention (PCI)
o Implantation of a cardiac resynchronization therapy device (CRTD)
o Carotid angioplasty
6. PCI, CABG or implantation of a CRTD planned between randomization and end of study
7. Sustained systolic blood pressure = 90 mmHg and?/?or signs and symptoms of hypotension prior to randomization
8. Sustained systolic blood pressure = 160 mmHg
9. Sustained bradycardia with heart rate < 50 beats/minute or tachycardia with heart rate >?100 beats/minute prior to randomization
10. Known clinically relevant ventricular arrhythmias (sustained ventricular tachycardia, ventricular flutter or fibrillation) within 3 months prior to consent based on either medical history or ICD-testing results (if applicable)
11. Clinically relevant permanent or intermittent AV-block > grade II in patients without a permanent pacemaker or ICD?/?CRT device
12. Severe valvular disease with indicated or planned valve repair?/?replacement
13. Listing for heart transplantation and / or anticipated implantation of a ventricular assist device
14. Severe pulmonary disease with any of the following:
o Requirement of continuous (home) oxygen or
o History of COPD = GOLD III or
o Asthma bronchiale
15. Anemia with hemoglobin < 10 g/dL within 3 months prior to randomization. If several values are available the latest result should be used.
16. Body Mass index (BMI) > 40 kg/m2 at randomization or a history of poor quality LVEF measurement by echocardiography

Study & Design

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