The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 April 2021
• 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: 30
• Recruitment status: Completed
• 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: Torsten Bloch Rasmussen, MD, PhD
• Affiliation: Aarhus University Hospital, Department of Cardiology

• Name: Steen Hvitfeldt Poulsen, MD
• Affiliation: Aa

• Name: Morten Kvistholm Jensen, MD, PhD
• 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: Placebo oral capsule

Drug: Metoprolol Succinate

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]

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]

VO2-max [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]

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]

Secondary ID(s)

1-10-72-441-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors