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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
Novartis Investigative Site
Greifswald, Mecklenburg-Vorpommern, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
München, Germany
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.
Time frame: 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)
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.
Time frame: 4 and 5 hours after exercise testing session
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.
Time frame: 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)
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.
Time frame: 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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Novartis Investigative Site
München, Germany
Novartis Investigative Site
Basel, Switzerland
Novartis Investigative Site
Hull, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Tyne and Wear, United Kingdom