Chronic Heart Failure MedDRA version: 19.1 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent before any assessment is performed. 2. Male or female = 18 years of age, with body weight = 160 Kg. 3. Diagnosis of stable CHF: - New York Heart Association (NYHA) functional Class II and III. - Receiving guideline-recommended treatment for CHF. 4. Left ventricular ejection fraction 250 ng/L in sinus rhythm or > 750 ng/L if not in sinus rhythm (determined locally). 6. Ability to exercise for at least 10 to 12 minutes based on investigator's judgment. 7. Systolic BP = 125 mmHg at screening. 8. Renal function defined as an eGFR of = 25 mL/min/1.73 m2 at 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Dyspnea primarily due to non-cardiac causes. 2. Worsening symptoms, e.g., fatigue, dyspnea, breathlessness within the 3 months prior to screening. 3. Increased risk of developing hypotension during vasodilator therapy according to investigators judgement. 4. Any contraindication for exercise testing and spirometry. 5. Stopping of the spirometry at screening according to the stopping rules, unless the patient has reached maximum exercise capacity defined as carbon dioxide production/oxygen consumption (VCO2/VO2) > 1.05. 6. Change in guideline-recommended CHF treatment within 1 month prior to screening. 7. Clinical evidence of acute coronary syndrome within 90 days prior to enrollment. 8. Significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate 90 beats per minute at rest. 9.Severe renal impairment defined as eGFR < 25 mL/min/1.73m2 before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of short-term i.v. administration of serelaxin in CHF patients on the geometric mean of hs-cTnI concentrations compared to placebo (both in addition to SoC) after an exercise testing session. ; Secondary Objective: - To evaluate the effect of short-term i.v. administration of serelaxin in CHF patients on the geometric mean of hs-cTnI concentrations compared to placebo at 4 and 5 hours after the start of an exercise testing session. - To evaluate the effect of short-term i.v. administration of serelaxin in CHF patients on the geometric mean of N terminal pro-brain natriuretic peptide (NT-proBNP) concentrations after an exercise testing session. - To evaluate the effect of short-term i.v. administration of serelaxin in CHF patients on the geometric mean of heart-type fatty acid-binding protein (H-FABP). - To evaluate the safety and tolerability of i.v. serelaxin in CHF patients. ;Primary end point(s): determine changes in plasma concentrations of hs cTnI following a cardiac stress test;Timepoint(s) of evaluation of this end point: at 0, 132, 180, 240, 300, 360, 420 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - efficacy: at 0, 132, 180, 240, 300, 360, 420 minutes - safety: at screening and start of the infusion for both treatment period as well as at Day 29 (follow up period 15 days after treatment period 2) ; Secondary end point(s): - Determine changes in plasma concentrations of hs cTnI, NT-proBNP and H-FABP following a cardiac stress test. (efficacy) - ECG, Physical examination, vital signs, Laboratory evaluation, Clinical chemistry, Hematology (safety) | — |
Countries
Germany, Switzerland, United Kingdom
Contacts
Public ContactMedical Information Services
Novartis Pharmaceuticals UK Ltd
Outcome results
None listed