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Beta 3 Agonist Treatment in Heart Failure-2

NCT03926754 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-05-04

No results posted yet for this study

Summary

Objective: The objective of the study is to assess the structural and functional cardiac effects of treatment with the beta 3 AR agonist Mirabegron in patients with moderate to severe chronic heart failure (LVEF\<35%, NYHA III-IV).

The study is a randomized, placebo-controlled, double-blinded trial in two phases with two hypotheses:

Chronic study - study A: Long-term treatment (3 months) with the β3 adrenergic receptor agonist Mirabegron is beneficial in patients with moderate to severe human heart failure

Invasive study - Study B: Administration of Mirabegron in patients with heart failure leads to an immediate increase in cardiac output at a constant or reduced left ventricular filling pressure during submaximal exercise

Specific aims

1. Determine safety of administration of Mirabegron to patients with moderate to severe heart failure.
2. Determine if treatment with Mirabegron for 3 months induces beneficial cardiac structural remodelling in patients with moderate to severe heart failure. In an open-label follow-up to determine the effects of Mirabegron after an extended duration (a total of 12 months).
3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with moderate to severe heart failure.
4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with moderate to severe heart failure.
5. Determine effects of Mirabegron on circulating biomarkers in patients with moderate to severe heart failure.
6. Determine the immediate and short term haemodynamic effects of Mirabron as measured by CT and invasively.

Conditions

  • Heart Failure With Reduced Ejection Fraction NYHA Class III-IV

Interventions

DRUG

Mirabegron

Study A The maximum tolerated dose up to a maximum of 300 mg per day for 26 weeks. Study B One single dose of 300 mg at day one followed by 150 mg x 2 for 1 week (8-11 days).

Sponsors & Collaborators

  • Bispebjerg-Frederiksberg Hospital, Denmark

    collaborator UNKNOWN

  • Hillerød hospital, Denmark

    collaborator UNKNOWN

  • Herlev Hospital

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Bornholm Hospital, Denmark

    collaborator UNKNOWN

  • Royal North Shore Hospital

    collaborator OTHER

  • Henning Bundgaard

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2021-01-21
Completion
2021-01-21

Countries

  • Denmark

Study Locations

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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 NCT03926754 on ClinicalTrials.gov