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A Study of CLR325 in Chronic Stable Heart Failure Patients. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of CLR325 in Chronic Stable Heart Failure Patients.

A Randomized, Subject and Investigator-blind, Placebo-controlled Study of CLR325 in Chronic Stable Heart Failure Patients

NCT02696967•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (11)

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

Key Dates

Start Date

May 17, 2016

Primary Completion Date

January 14, 2019

Completion Date

January 14, 2019

Last Updated

January 5, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Stable Heart Failure

Interventions

CLR325

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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