Clinical trial NCT02625922: Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
Official title: A Multicenter, Randomized, Double-blind, Crossover Placebo-controlled Phase II Study to Assess the Effect of Serelaxin Versus Placebo on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure After Exercise When Used in Addition to Standard of Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Heart Failure
Keywords: Serelaxin,
Chronic heart failure,
Spiroergometry,
Troponin,
New York Heart Association (NYHA) functional Class II/III,
Left ventricular ejection fraction,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo
timeFrame: 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 outcomes:
measure: Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours
timeFrame: 4 and 5 hours after exercise testing session
measure: Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo
timeFrame: 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)
measure: Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo
timeFrame: 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)
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Novartis Investigative Site
state: Mecklenburg Vorpommern
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Hull
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Tyne And Wear
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: