Beta 3 Agonist Treatment in Heart Failure (Beat-HF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01876433|
Recruitment Status : Unknown
Verified June 2015 by Henning Bundgaard, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : June 12, 2013
Last Update Posted : June 11, 2015
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 chronic heart failure.
Design: We are planning a study aiming at establishing proof of concept that treatment of patients with HF with Mirabegron has significant positive effects, as assessed by clinical and biochemistry measurements, but not by hard endpoints. We are performing a combined dose-finding - chronic efficacy study.
The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up period is 6 months. 70 patients with chronic heartfailure will be included.
- Determine safety of administration of Mirabegron to patients with heart failure.
- Determine if treatment with Mirabegron for 6 months induces beneficial cardiac structural remodelling in patients with heart failure.
- Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with heart failure.
- Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with heart failure.
- Determine effects of Mirabegron on circulating biomarkers in patients with heart failure.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)||Drug: Mirabegron Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Beta 3 Agonist Treatment in Heart Failure|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
Active Comparator: Beta-3-agonist
Mirabegron 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2.
Other Name: Beta 3 agonist
Placebo Comparator: Placebo
Placebo 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2.
- Increase in LVEF (measured by MRI or CT) [ Time Frame: 6 months ]
- A reduction in NT proBNP [ Time Frame: 6 months ]
- An increase in 6 min walking distance [ Time Frame: 6 months ]
- An increase in CO/SV [ Time Frame: 6 months ]
- A reduction in LVIDd [ Time Frame: 6 months ]
- An improvement in diastolic function [ Time Frame: 6 months ]
- A reduction in LA volume [ Time Frame: 6 months ]
- A reduction in LV diameters [ Time Frame: 6 months ]
- A shortening of the QT interval [ Time Frame: 6 months ]
- Improvement in quality of life [ Time Frame: 6 monhs ]
- Improvement in functional class [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876433
|Contact: Henning Bundgaard, MD, DMSciemail@example.com|
|Monash Center of Cardiovascular Research.||Not yet recruiting|
|Contact: Henry Krum, MD, Professor|
|Principal Investigator: Henry Krum, MD, Professor|
|Department of Cardiology, Royal North Shore Hospital.||Not yet recruiting|
|Contact: Helge Rasmussen, MD, Professor|
|Principal Investigator: Helge Rasmussen, MD, Professor|
|Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital.||Recruiting|
|Copenhagen Ø, Denmark, 2100|
|Contact: Henning Bundgaard, MD, DMSci +4535450512 firstname.lastname@example.org|
|Principal Investigator: Henning Bundgaard, MD, PhD, DMSc|
|Principal Investigator:||Henning Bundgaard, MD, PhD, DMSc||Rigshospitalet Copenhagen University Hospital, Department of Cardiology|