A Study of CLR325 in Chronic Stable Heart Failure Patients.

Phase 1

• Conditions: Stable Heart Failure; MedDRA version: 20.0 Level: PT Classification code 10007558 Term: Cardiac failure chronic System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-001387-12-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-30
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

•Written informed consent must be obtained before any assessment is
performed.
•Able to communicate well with the investigator, to understand and
comply with the requirements of the study.
•Male and female patients >18 years of age.
•Patients must weigh between 50kg and 140 kg to participate in the
study.
•Patients with a cardiac ejection fraction of = 45% as assessed within
the last 6 months.
•For PA catheter cohorts, patients who are planned to have a clinically
indicated pulmonary artery catheter in place prior to randomization.
•In the opinion of the investigator, heart failure patients who will not
require a change in their dose of ACE, ARB, ß-blocker, mineralocorticoid
receptor antagonist, or diuretic for 24 hours after
randomization
•At baseline, vital signs (systolic and diastolic blood pressure and pulse
rate) will be assessed in the sitting position after the subject has rested
for at least five minutes.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Presence of impaired renal function as indicated by clinically significant
abnormal creatinine values (eGFR < 30 ml/min/1.73m^2 calculated
using the MDRD equation).
•Patients with values of AST or ALT >100 U/L measured within
the last 3 months before randomization.
•Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). A
positive Hepatitis B surface antigen (HBsAg) test excludes a
patient. Patients with a positive Hepatitis C antibody test should
have HCV RNA levels measured. Patients with positive
(detectable) HCV RNA should be excluded.
•Patients with a history of chronic hepatitis of any non-cardiac
etiology.
•History of any active, clinically significant cardiac tachyarrhythmia,
such as recurrent atrial fibrillation with rapid ventricular response within
the last year. Anticoagulation for patients with atrial fibrillation should
be managed per usual clinical practice for patients undergoing right
heart catheterization.
•For Echocardiography-based cohort only, patients admitted to an
inpatient setting for acute decompensated heart failure within the last
30 days.
•Patients who have received an intravenous infusion of a cardiac
inotrope (e.g.,dobutamine or milrinone) in the last 24 hours prior to
randomization.
•For PA catheter cohorts, patients with a pulmonary capillary wedge
pressure of <10 mm Hg at baseline. For echocardiographic cohorts,
patients with a lateral E/E' ratio of <7 on their baseline
echocardiogram. For patients in whom a lateral E/E' ratio cannot be
determined (e.g., patients in atrial fibrillation), a central venous
pressure of <5mm Hg on baseline echocardiogram as determined by
inferior vena cava criteria.
•Patients with any significant change in their dose of their ACE, ARB,
mineralocorticoid receptor antagonist, diuretic or ß-blocker within the
last 12 hours.
•Patients with minor changes in their heart failure regimen may be
eligible if deemed clinically stable by both the investigator and
sponsor.
•Patients with known significant valvular heart disease, as indicated
by the following:
- Severe aortic stenosis (Aortic Valve Area < 1.0 cm^2 or peak
gradient > 50 mmHg as determined by echocardiography)
- Severe mitral stenosis
•Patients with history of acute coronary syndrome within the last 60
days as determined by both clinical and enzymatic criteria.

Study & Design

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