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Hypertrophic CardiomyopathyPhase 4NCT04133532

Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy

A Phase 4 study testing Metoprolol in people with Hypertrophic Cardiomyopathy, run by University Hospital, Motol at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation. The investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertrophic Cardiomyopathy
What is being tested?
Metoprolol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCzechia
Study dates
5 Mar 2020to 23 Feb 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients post alcohol septal ablation
  • Pressure gradient in left ventricular outflow tract <30 mmHg
  • Written consent to participate

Who cannot join

  • History of atrial fibrillation
  • Symptoms of Class III or IV of New York Heart Association functional classification
  • Permanent pacemaker implant
  • Age above 75

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Motol University Hospital

    Prague, Czech Republic, 15000

Other trials in Czechia

About this study

In this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation. The investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury.

Read the detailed description

In this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation.

The investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury.

The investigators will enroll 50 patients that will meet all the inclusion criteria and will agree to participate in the trial. In patients with preceding beta-blocker medication, it will be discontinued and a washout period of one month will be provided. The investigators will assess baseline characteristics and then divide patients randomly into two arms based on their date of birth (even/odd days of the month).

Arm A will be given metoprolol 50 mg daily for three months, after this period the effect will be evaluated and metoprolol discontinued. A month-long washout period will follow and after an additional three months without metoprolol medication, patients will be reevaluated.

Arm B will be without metoprolol for three months and will be evaluated thereafter. Then the patients will be given metoprolol 50 mg daily for three months followed by a reevaluation.

The investigators will evaluate the effect of metoprolol by multiple methods at the end of the 5th and 9th months of the trial. Quality of life will be assessed by a questionnaire (The Kansas City Cardiomyopathy Questionnaire), exercise tolerance by a spiroergometry (VO2 max). A conventional echocardiographic examination and an examination focused on exercise-induced left ventricular outflow tract obstruction will be performed. The investigators will also measure NTproBNP from a blood sample as a laboratory marker of heart failure and high sensitive troponin as a marker of myocardial injury.

Being tested
Metoprolol
Keywords
Exercise tolerance, NTproBNP, Left ventricular outflow tract obstruction, Quality of life, Diastolic dysfunction
Medical subject headings
Cardiomyopathy, Hypertrophic, Ventricular Outflow Obstruction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetoprololDrug

    metoprolol 50 mg daily for three months

Study groups in NCT04133532
Study groupRoleWhat they receive
metoprolol-no metoprololExperimentalAfter a washout period of one month following discontinuation of preceding beta-blocker medication patients will be given metoprolol 50 mg daily. The effect will be evaluated after three months of treatment. After that, another one-month washout period will commence followed by three months without metoprolol medication. Then, a final reevaluation will be performed.
Receives: Drug: Metoprolol
no metoprolol-metoprolExperimentalAfter a one-month washout period following discontinuation of preceding beta-blocker medication patients will continue another three months without a metoprolol medication. After that, an evaluation will be performed. Then they will be given metoprolol 50 mg daily for three months followed by a reevaluation.
Receives: Drug: Metoprolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in exercise tolerance with and without metoprolol

    VO2max during bicycle ergometer exercise test

    Measured: At baseline, after three months of metoprolol medication, after three months without metoprolol medication

Secondary outcomes (5)

  1. Change of quality of life with and without metoprolol: The Kansas City Cardiomyopathy Questionnaire

    The Kansas City Cardiomyopathy Questionnaire, score 0-100 (higher score means better outcome)

    Measured: After three months of metoprolol medication, after three months without metoprolol medication

  2. Change of concentration of biomarker of heart failure with and without metoprolol

    N-Terminal Pro-Brain Natriuretic Peptide concentration in blood sample

    Measured: After three months of metoprolol medication, after three months without metoprolol medication

  3. Change of concentration of a biomarker of myocardial injury with and without metoprolol

    High sensitivity troponin concentration in blood sample

    Measured: After three months of metoprolol medication, after three months without metoprolol medication

  4. Change in exercise induced pressure gradient in left ventricular outflow tract with and without metoprolol

    mmHg

    Measured: After three months of metoprolol medication, after three months without metoprolol medication

  5. Change in left ventricular diastolic function at rest with and without metoprolol

    Echocardiographic parameters of the transmitral flow and tissue Doppler

    Measured: After three months of metoprolol medication, after three months without metoprolol medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start5 Mar 2020
  3. Primary completion23 Feb 2023
  4. Study completion23 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
We will enroll 50 patients and divide them into two arms. Initially, arm A will be given metoprolol and arm B will not. We will evaluate the two groups after a sufficient time period (three months) and after that, patients will cross-over to the other treatment strategy for three months followed by a final evaluation.
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133532
Sponsor's protocol ID
HCMBB
Status last verified
May 2023
First submitted
16 Oct 2019
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 13;124(24):e783-831. doi: 10.1161/CIR.0b013e318223e2bd. Epub 2011 Nov 8. No abstract available.

    PubMed 22068434

  • Maron BJ, McKenna WJ, Danielson GK, Kappenberger LJ, Kuhn HJ, Seidman CE, Shah PM, Spencer WH 3rd, Spirito P, Ten Cate FJ, Wigle ED; Task Force on Clinical Expert Consensus Documents. American College of Cardiology; Committee for Practice Guidelines. European Society of Cardiology. American College of Cardiology/European Society of Cardiology clinical expert consensus document on hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents and the European Society of Cardiology Committee for Practice Guidelines. J Am Coll Cardiol. 2003 Nov 5;42(9):1687-713. doi: 10.1016/s0735-1097(03)00941-0. No abstract available.

    PubMed 14607462

  • HARRISON DC, BRAUNWALD E, GLICK G, MASON DT, CHIDSEY CA, ROSS J Jr. EFFECTS OF BETA ADRENERGIC BLOCKADE ON THE CIRCULATION WITH PARTICULAR REFERENCE TO OBSERVATIONS IN PATIENTS WITH HYPERTROPHIC SUBAORTIC STENOSIS. Circulation. 1964 Jan;29:84-98. doi: 10.1161/01.cir.29.1.84. No abstract available.

    PubMed 14105035

  • Cohen LS, Braunwald E. Amelioration of angina pectoris in idiopathic hypertrophic subaortic stenosis with beta-adrenergic blockade. Circulation. 1967 May;35(5):847-51. doi: 10.1161/01.cir.35.5.847. No abstract available.

    PubMed 6067064

  • Fananapazir L, Chang AC, Epstein SE, McAreavey D. Prognostic determinants in hypertrophic cardiomyopathy. Prospective evaluation of a therapeutic strategy based on clinical, Holter, hemodynamic, and electrophysiological findings. Circulation. 1992 Sep;86(3):730-40. doi: 10.1161/01.cir.86.3.730.

    PubMed 1516184

  • Gilligan DM, Chan WL, Joshi J, Clarke P, Fletcher A, Krikler S, Oakley CM. A double-blind, placebo-controlled crossover trial of nadolol and verapamil in mild and moderately symptomatic hypertrophic cardiomyopathy. J Am Coll Cardiol. 1993 Jun;21(7):1672-9. doi: 10.1016/0735-1097(93)90386-f.

    PubMed 8496536

  • Nistri S, Olivotto I, Maron MS, Ferrantini C, Coppini R, Grifoni C, Baldini K, Sgalambro A, Cecchi F, Maron BJ. beta Blockers for prevention of exercise-induced left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. Am J Cardiol. 2012 Sep 1;110(5):715-9. doi: 10.1016/j.amjcard.2012.04.051. Epub 2012 May 24.

    PubMed 22633205

  • Fifer MA, Vlahakes GJ. Management of symptoms in hypertrophic cardiomyopathy. Circulation. 2008 Jan 22;117(3):429-39. doi: 10.1161/CIRCULATIONAHA.107.694158. No abstract available.

    PubMed 18212300

  • Desai MY, Bhonsale A, Patel P, Naji P, Smedira NG, Thamilarasan M, Lytle BW, Lever HM. Exercise echocardiography in asymptomatic HCM: exercise capacity, and not LV outflow tract gradient predicts long-term outcomes. JACC Cardiovasc Imaging. 2014 Jan;7(1):26-36. doi: 10.1016/j.jcmg.2013.08.010. Epub 2013 Nov 27.

    PubMed 24290569

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metoprolol in people with Hypertrophic Cardiomyopathy, run by University Hospital, Motol at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in exercise tolerance with and without metoprolol (time frame: At baseline, after three months of metoprolol medication, after three months without metoprolol medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133532, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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