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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03532802
Date of registration: 19/04/2018
Prospective Registration: Yes
Primary sponsor: Steen Hvitfeldt Poulsen
Public title: The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy. TEMPO
Scientific title: The Effect of Metoprolol on Myocardial Function, Perfusion, Hemodynamics and Heart Failure Symptoms in Patients With Hypertrophic Obstructive Cardiomyopathy.
Date of first enrolment: May 1, 2018
Target sample size: 32
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03532802
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
Denmark
Contacts
Name:     Anne Dybro, MD
Address: 
Telephone: 26112115
Email: annedybr@rm.dk
Affiliation: 
Name:     Anne Dybro, MD
Address: 
Telephone: 0045-26112115
Email: annedybr@rm.dk
Affiliation: 
Name:     Steen Hvitfeldt Poulsen, MD
Address: 
Telephone:
Email:
Affiliation:  Aa
Name:     Morten Kvistholm Jensen, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Aarhus University Hospital, Department of Cardiology
Name:     Torsten Bloch Rasmussen, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Aarhus University Hospital, Department of Cardiology
Key inclusion & exclusion criteria

Inclusion Criteria:

- Wall thickness = 15 mm in one or more myocardial segments that is not explained by
loading conditions.

- LVOT gradient > 30 mmHg at rest and/or > 50 mmHg at Valsalva's maneuver or exercise

- New York Heart Association Functional class (NYHA) = II

Exclusion Criteria:

- Age < 18 years

- Known allergy to trial medicine

- Contraindications to beta-blocker treatment

- Contraindications to Magnetic resonans scan, including contraindication to the
contrast agent gadolinium.

- Female patients who are pregnant (positive plasma-HCG), breastfeeding or of
child-bearing potential while not practicing effective chemical contraceptive
hormones.

- In case of patients having a pacemaker, they may not be pace-dependent.

- Treatment with Amiodarone

- Atrial fibrillation/flutter at the time of examination

- Bradycardia < 49 beats/min

- Systolic blood pressure < 100 mmHg

- Trifascicular block

- Previous transcoronary ablation of septum hypertrophy (TASH) or myectomy

- Current abuse of alcohol and/or drugs

- Significant co-morbidity or issues that makes the patient unsuitable for
participation, judged by the investigator

- Patients who cannot give valid consent (e.g. mental illness or dementia)

- Patients who do not understand danish



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Hypertrophic Cardiomyopathy
Intervention(s)
Drug: Metoprolol Succinate
Drug: Placebo oral capsule
Primary Outcome(s)
?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]
Secondary Outcome(s)
Changes of symptoms and quality of life with Kansas City Cardiomyopathy Questionnaire [Time Frame: Changes will be evaluated after an expected average of 2 weeks of treatment in both treatment arms]
Coronary flow reserve [Time Frame: Changes will be evaluated after an expected average of 2 weeks of treatment in both treatment arms]
LVOT gradient during maximum exercise [Time Frame: Changes will be evaluated after an expected average of 2 weeks of treatment in both treatment arms]
N-terminal prohormone of brain natriuretic peptide [Time Frame: Changes will be evaluated after an expected average of 2 weeks of treatment in both treatment arms]
Pulmonary capillary wedge pressure at rest [Time Frame: Changes will be evaluated after an expected average of 2 weeks of treatment in both treatment arms]
VO2-max [Time Frame: Changes will be evaluated after an expected average of 2 weeks of treatment in both treatment arms]
Secondary ID(s)
1-10-72-441-17
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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