Beta3 Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure (NCT02775539) | Clinical Trial Compass
UnknownPhase 2
Beta3 Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure
80 participantsStarted 2016-06
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of mirabegron (a B3 adrenergic receptor agonist) in patients with pulmonary hypertension secondary to heart failure by conducting a randomized multicenter phase II placebo-controlled clinical trial.
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.
Inclusion Criteria:
* Written inform consent;
* \>18 years-old;
* HF with reduced or preserved ejection fraction, according to the definition of the European Society of Cardiology guidelines.
* Severe PH and/or combined postcapillary and precapillary PH (also knows as reactive or out-of-proportion PH) determined by RHC showing the following:
* Pulmonary arterial wedge pressure or end-diastolic left ventricular pressures ≥15 mmHg;
* Mean PAP≥25, and:
* PVR≥3 UW and/or diastolic gradient≥7 mmHg or
* Transpulmonary gradient≥12.
* NYHA functional class II-IV;
* On optimized evidence-based pharmacological treatment;
* Stable clinical condition defined as no changes in therapeutic regimen or hospitalization in the 30 days preceding recruitment and no current plan for changing therapy.
Exclusion Criteria:
* Non-coronary cardiac surgery or non-coronary percutaneous procedure within the 12 months preceding recruitment or programmed;
* Myocardial infarction or coronary revascularization during the last 3 months,
* Myocardial resynchronization therapy initiated during the last 6 months;
* Sinus tachycardia or atrial fibrillation with uncontrolled heart rate (\>100 bpm);
* Uncontrolled hypertension (PAS\>180 or PAD\>110 mmHg) or symptomatic hypotension (PAS\<90 mmHg).
* Infiltrative myocardial disease.
* Expected survival \<1 year due to a disease other than PH;
* Severe renal failure (GFR \<30 mL/min/1.73 m2 or haemodialysis);
* Severe hepatic impairment (serum aspartate ami…
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
Change in pulmonary vascular resistance (PVR) from baseline to week 16 assessed by right heart catheterization (RHC).
Timeframe: 16 weeks
Trial details
NCT IDNCT02775539
SponsorFundación Centro Nacional de Investigaciones Cardiovasculares Carlos III