A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.

Phase 2

Completed

• Conditions: Acute Heart Faillure; 10019280

• Registration Number: NL-OMON37099
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Patients admitted to hospital or who require admission to hospital for management of acute heart failure with shortness of breath at rest or minimal exertion
- stabilized within 2 days after admission
- normal or elevated systolic blood pressure
- elevated pulmonary capilary wedge pressure measured by Swan-Ganz catheterization

Exclusion Criteria

- severe renal impairment
- significant liver impairment
- significant lung impairment
- significant heart valve dysfunction or arrythmias
- myocardial infarction or acute coronary syndrome within th elast 45 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Pulmonary capillary wedge pressure (PCWP)<br /><br>- Right atrial pressure (RAP)<br /><br>- Systolic and diastolic pulmonary artery pressure (PAP)<br /><br>- Pulmonary oxygen saturation (pO2) and<br /><br>- Cardiac output (CO)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>a.Non-invasive measurement of central aortic systolic pressure and<br /><br>radial arterial pulse waveform<br /><br>b.Pharmacokinetics<br /><br>c.Total urine volume<br /><br>d.Safety and tolerability<br /><br>e.Sodium and creatinine excretion</p><br>