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 range18 Years
SexALL
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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 ā„15 mmHg;
* Mean PAPā„25, and:
* PVRā„3 UW and/or diastolic gradientā„7 mmHg or
* Transpulmonary gradientā„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 amiā¦
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