The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy. (TEMPO)
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| ClinicalTrials.gov Identifier: NCT03532802 |
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Recruitment Status :
Recruiting
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
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Sponsor:
Steen Hvitfeldt Poulsen
Information provided by (Responsible Party):
Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | April 19, 2018 | |||||||||
| First Posted Date ICMJE | May 22, 2018 | |||||||||
| Last Update Posted Date | May 22, 2018 | |||||||||
| Actual Study Start Date ICMJE | May 1, 2018 | |||||||||
| Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
∆Pulmonary capillary wedge pressure (rest-exercise) [ Time Frame: Changes will be evaluated after an expected average of 2 weeks of treatment in both treatment arms ] Changes in pulmonary capillary wedge pressure in mmHg from rest to exercise, measured during right heart catheterization
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy. | |||||||||
| Official Title ICMJE | The Effect of Metoprolol on Myocardial Function, Perfusion, Hemodynamics and Heart Failure Symptoms in Patients With Hypertrophic Obstructive Cardiomyopathy. | |||||||||
| Brief Summary | Hypertrophic obstructive cardiomyopathy (HOCM) patients often develop disabling symptoms of heart failure. Current treatment strategies are predicated on the empirical use of long-standing drugs, such as beta-adrenergics, although with little evidence supporting their clinical benefit in this disease. Metoprolol is currently the most widely used beta-blocker in symptomatic HOCM patients, but a randomized, placebo-controlled trial, that looks at the effect in HOCM patients has never been conducted. No studies of HOCM combine invasive pressure measurement with exercise and echocardiography. All previous studies, both invasive and echocardiographic, have been conducted during rest, and not during exercise. Symptoms of HOCM patients are function-related, and exercise testing is essential to assess the condition and the effect of drugs. | |||||||||
| Detailed Description | Background Hypertrophic cardiomyopathy (HCM) is characterized by an increase in left-ventricular wall thickness, typically localized at the interventricular septum. The hypertrophy can increase to an extend that causes a dynamic obstruction of the left ventricular outflow tract (LVOTO); these patients have hypertrophic obstructive cardiomyopathy (HOCM). Due to the obstruction, patients develop high interventricular pressure gradients, which may overtime become detrimental to the left ventricular function. HOCM patients often develop disabling symptoms of heart failure. Current treatment strategies are predicated on the empirical use of long-standing drugs, such as beta-adrenergics, although with little evidence supporting their clinical benefit in this disease. Metoprolol is currently the most widely used beta-blocker in symptomatic HOCM patients, but a randomized, placebo-controlled trial, that looks at the effect in HOCM patients has never been conducted. No studies of HOCM combine invasive pressure measurement with exercise and echocardiography. All previous studies, both invasive and echocardiographic, have been conducted during rest, and not during exercise. Symptoms of HOCM patients are function-related, and exercise testing is essential to assess the condition and the effect of drugs. Objective We want to quantify the effects of metoprolol on myocardial function and perfusion, hemodynamics and heart failure symptoms in patients with HOCM. Hypotheses Primary • Metoprolol treatment reduces ∆ pulmonary capillary wedge pressure (PCWP) (rest-exercise) Secondary
Design and methods A randomized, double-blinded, placebo-controlled, crossover study. We will examine 32 patients with HOCM both during treatment with metoprolol and placebo. Patients will be examined in a set-up of simultaneous 1) right heart catheterization 2) cardiopulmonary exercise test and 3) transthoracic echocardiography. The set-up allows us to evaluate the hemodynamic values during rest and maximum exercise. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 2 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Hypertrophic Cardiomyopathy | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE |
32 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | May 1, 2021 | |||||||||
| Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Denmark | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03532802 | |||||||||
| Other Study ID Numbers ICMJE | 1-10-72-441-17 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby | |||||||||
| Study Sponsor ICMJE | Steen Hvitfeldt Poulsen | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Aarhus University Hospital Skejby | |||||||||
| Verification Date | May 2018 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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