A Study of CLR325 in Chronic Stable Heart Failure Patients.

NCT ID: NCT02696967

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-17
• Study Completion Date: 2019-01-14

Brief Summary

The purpose of this study was to determine the safety and tolerability of CLR325 intravenous (i.v.) infusion in patients with stable heart failure to determine if further clinical development of the drug in this indication was warranted.

Conditions

Chronic Stable Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CLR325

Patients were assigned to one of the 2 treatment arms in fixed randomization ratio. Patients randomized to this arm received single dose of CLR325 (i.v.) in double blind manner.

Group Type: EXPERIMENTAL

CLR325

Intervention Type: DRUG

CLR325 Concentrate for solution for infusion

Placebo

Patients were assigned to one of the 2 treatment arms in fixed randomization ratio. Patients randomized to this arm received single dose of placebo (i.v.) in double blind manner.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Normal saline

Interventions

CLR325

CLR325 Concentrate for solution for infusion

Intervention Type: DRUG

Placebo

Normal saline

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male and female patients >18 years of age
• Body weight between 50 kg and 140 kg
• Cardiac ejection fraction of ≤ 45% 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 do not require a change in their dose of acetylcholinesterase (ACE), angiotensin receptor blocker (ARB), β-blocker, mineralocorticoid receptor antagonist, or diuretic for 24 h after randomization.
• At Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) assessment in the supine position after the subject has rested for at least five minutes.

Exclusion Criteria

• Impaired renal function as indicated by clinically significant abnormal creatinine values (Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 calculated using the Modification of Diet in Renal Disease Study (MDRD) equation)
• History of chronic hepatitis of any non-cardiac etiology
• History of any active or clinically significant cardiac tachyarrhythmia (such as recurrent atrial fibrillation with rapid ventricular response within the last year) and patients with chronic atrial fibrillation with a pulse rate ≤ 100 bpm
• Patients who received an i.v. infusion of a cardiac inotrope (e.g., dobutamine or milrinone) in the last 24 h prior to randomization
• Patients with any significant change in their dose of their ACE, ARB, mineralocorticoid receptor antagonist, diuretic, or β-blocker within the last 12 h
• Patients with known significant valvular heart diseases indicated by the following:

• severe aortic stenosis (aortic valve area < 1.0 cm2 or peak gradient > 50 mm Hg as determined by echocardiography)
• severe mitral stenosis
• History of acute coronary syndrome within the last 60 days as determined by both clinical and enzymatic criteria
• For echocardiography-based cohorts only, patients admitted to an inpatient setting for acute decompensated heart failure within the last 30 days
• 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 < 5 mm Hg on baseline echocardiogram as determined by inferior vena cava criteria.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Chicago, Illinois, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Cleveland, Ohio, United States

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

Tacoma, Washington, United States

Novartis Investigative Site

Aalst, , Belgium

Novartis Investigative Site

Regensburg, Bavaria, Germany

Novartis Investigative Site

Greifswald, , Germany

Novartis Investigative Site

Amsterdam, , Netherlands

Novartis Investigative Site

Singapore, , Singapore

Countries

United States; Belgium; Germany; Netherlands; Singapore

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=476

A Plain Language Trial Summary is available on novartisclinicatrials.com

Other Identifiers

2016-001387-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCLR325X2202

Identifier Type: -

Identifier Source: org_study_id