Beta3 Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure

NCT02775539 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-05-17

No results posted yet for this study

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.

Conditions

  • Pulmonary Hypertension
  • Mirabegron
  • Heart Failure
  • Pulmonary Vascular Resistance Abnormality

Interventions

DRUG

Mirabegron

Patients will receive 50 to 200 mg of mirabegron once a day during 16 weeks. Dose will be titrated during the first 8 weeks.

DRUG

Placebo

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER
  • Hospital Universitario 12 de Octubre

    collaborator OTHER
  • Puerta de Hierro University Hospital

    collaborator OTHER
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER
  • Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-01-31
Completion
2019-06-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02775539 on ClinicalTrials.gov