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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02064868
Other study ID # CRLX030A3301
Secondary ID 2013-002513-35
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 31, 2014
Est. completion date April 25, 2017

Study information

Verified date December 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).


Description:

This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).


Recruitment information / eligibility

Status Terminated
Enrollment 2666
Est. completion date April 25, 2017
Est. primary completion date March 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Systolic blood pressure = 125 mmHg

- Admitted for Acute Heart Failure (AHF)

- Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening

- eGFR on admission: = 25 and =75 mL/min/1.73 m^2

Exclusion Criteria:

- Dyspnea (non-cardiac causes)

- T > 38.5°C

- Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.

- Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm^2 or mean gradient >50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis.

- AHF due to significant arrhythmias

- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Serelaxin
30 µg/kg/day IV infusion
Standard of Care
This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.

Locations

Country Name City State
Austria Novartis Investigative Site Feldkirch
Austria Novartis Investigative Site Graz
Austria Novartis Investigative Site Linz
Austria Novartis Investigative Site Salzburg
Austria Novartis Investigative Site Salzburg
Austria Novartis Investigative Site St. Poelten
Austria Novartis Investigative Site Vienna
Austria Novartis Investigative Site Vienna
Austria Novartis Investigative Site Wien
Belgium Novartis Investigative Site Aalst
Belgium Novartis Investigative Site Brugge
Belgium Novartis Investigative Site Brussel
Belgium Novartis Investigative Site Gent
Belgium Novartis Investigative Site Hasselt
Belgium Novartis Investigative Site Leuven
Belgium Novartis Investigative Site Liege
Belgium Novartis Investigative Site Lodelinsart
Belgium Novartis Investigative Site Mol
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Belgium Novartis Investigative Site Roeselare
Belgium Novartis Investigative Site Ronse
Belgium Novartis Investigative Site Turnhout
Bulgaria Novartis Investigative Site Gabrovo
Bulgaria Novartis Investigative Site Plovdiv
Bulgaria Novartis Investigative Site Ruse
Bulgaria Novartis Investigative Site Sliven
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Veliko Tarnovo
Croatia Novartis Investigative Site Varazdin HRV
Croatia Novartis Investigative Site Zagreb
Czechia Novartis Investigative Site Brno Czech Republic
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Czechia Novartis Investigative Site Karvina-Raj Czech Republic
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Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Croatia,  Czechia,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Iceland,  Italy,  Latvia,  Lithuania,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5 In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication. 5 days
Secondary Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14 WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators. 14 days
Secondary Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5 Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5. 5 days
Secondary Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14 Renal deterioration is defined as > or = 0.3 mg/dL increase from screening in serum creatinine. 14 days
Secondary Length of Index Hospital Stay Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time. 30 Days
Secondary Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days
Secondary Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire. EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state). Baseline, Day 5, Day 14
See also
  Status Clinical Trial Phase
Recruiting NCT05042752 - Impact of Clinical Ultrasound in Patients With Heart Failure Treated in Home Hospitalization N/A