A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-ControlledStudy to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure. - RELAX-AHF

Phase 1

• Conditions: Patients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment.; MedDRA version: 9.1Level: LLTClassification code 10000803Term: Acute heart failure

• Registration Number: EUCTR2007-004271-19-FR
• Lead Sponsor: Corthera, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-31
• Study Completion: 2012-08-14
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Able to provide written informed consent

2. Male or female = 18 years of age, with body weight <160 kg

3. Systolic blood pressure > 125 mmHg at the start of screening and at the end of screening

4. Hospitalized for AHF. AHF is defined as including all of the following measured at any

time between presentation (including the emergency department [ED]) and the end of

screening:

a. Dyspnea at rest or with minimal exertion

b. Pulmonary congestion on chest radiograph

c. BNP = 350pg/mL or NT-pro-BNP =1400 pg/mL

5. Able to be randomized within 16 hours from presentation to the hospital, including the ED

6. Received IV furosemide of at least 40 mg (or equivalent) at any time between admission

to emergency services (either ambulance or hospital, including the ED) and the start of

screening for the study

7. Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on

admission between 30-75 mL/min/1.73 m2, calculated using the simplified Modification

of Diet in Renal Disease (sMDRD) equation
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnant or breast-feeding women (women of child bearing potential must have the

results of a negative pregnancy test recorded prior to study drug administration)

2. Administration of intravenous radiographic contrast agent within 72 hours prior to

screening or acute contrast-induced nephropathy at the time of screening

3. Temperature >38°C (oral or equivalent) or sepsis or active infection requiring IV anti-

microbial treatment

4. Current (within 2 hours prior to screening) or planned (through the completion of study

drug infusion) treatment with any IV therapies, including vasodilators (including

nesiritide), positive inotropic agents and vasopressors, or mechanical support (intra-aortic

balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist

device), with the exception of IV nitrates at a dose of < 0.1 mg/kg/hr if the patient has a

systolic BP > 150 mmHg at screening

5. Current or planned ultrafiltration, hemofiltration, or dialysis

6. Known significant pulmonary disease

7. Known significant valvular disease (including any of the following: severe aortic stenosis

[AVA < 1.0 or peak gradient > 50 on prior or current echocardiogram], severe aortic

regurgitation, or severe mitral stenosis)

8. Any organ transplant recipient, or patient currently listed for transplant or admitted for

any transplantation

9. Major surgery within 30 days

10. Hematocrit < 25% or blood transfusion in the prior 14 days or active, life-threatening GI

bleeding

11. Major neurologic event, including cerebrovascular events, in the prior 60 days

12. Clinical diagnosis of acute coronary syndrome within 45 days prior to screening

(including the present admission) as determined by both clinical and enzymatic criteria

13. Troponin > 3 times the upper limit of normal (including borderline/intermediate)

between presentation and screening.

14. AHF due to significant arrhythmias (including any of the following: ventricular

tachycardia, bradyarrhythmias with ventricular rate <45 beats per minute or any second

or third degree AV block or atrial fibrillation/flutter with ventricular response of >120

beats per minute)

15. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive

cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler

echocardiographic assessments of diastolic function)

16. Known hepatic impairment

17. Non-cardiac pulmonary edema, including suspected sepsis

18. Administration of an investigational drug or implantation of investigational device, or

participation in another trial, within 30 days before screening or previous treatment with

relaxin

19. Inability to follow instructions or comply with follow-up procedures

Study & Design

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