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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02625922
Other study ID # CRLX030A2211
Secondary ID 2015-002673-38
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 5, 2016
Est. completion date January 11, 2017

Study information

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

Clinical Trial Summary

This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date January 11, 2017
Est. primary completion date January 11, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria:

- Male or female = 18 years of age, with body weight = 160 Kg

- Diagnosis of stable CHF:

- New York Heart Association (NYHA) functional Class II/III.

- Receiving guideline-recommended treatment for CHF.

- Left ventricular ejection fraction < 45%, obtained within the last 3 months prior to screening.

- NT-proBNP > 300 ng/L in sinus rhythm or > 900 ng/L if not in sinus rhythm (determined locally).

- Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.

- Systolic BP = 125 mmHg at randomization

- Renal function defined as an eGFR of = 25 mL/min/1.73 m^2 at screening (sMDRD formula).

Key Exclusion Criteria:

- Dyspnea primarily due to non-cardiac causes.

- Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.

- Any contraindication for exercise testing and spirometry.

- Stopping of the spiroergometry at screening according to the stopping rules, unless the patient has reached maximum exercise capacity defined as carbon dioxide production/oxygen consumption (VCO2/VO2) > 1.05.

- Change in guideline-recommended CHF treatment within 1 month prior to screening.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Serelaxin
Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen
Placebo
Matching placebo i.v infusion

Locations

Country Name City State
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Greifswald Mecklenburg Vorpommern
Germany Novartis Investigative Site Muenchen
Germany Novartis Investigative Site Muenchen
Switzerland Novartis Investigative Site Basel
United Kingdom Novartis Investigative Site Hull
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Tyne And Wear

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1)
Secondary Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. 4 and 5 hours after exercise testing session
Secondary Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)
Secondary Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test. Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)
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