Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Pati… (NCT02625922) | Clinical Trial Compass
TerminatedPhase 2
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
Stopped: In view of outcome of RELAX-AHF-2 trial, the entire RLX030A project was decided to be terminated.
Germany, Switzerland, United Kingdom26 participantsStarted 2016-02-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)