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2023-506283-13-00RecruitingPhase 4

Use of determination of drug levels to optimize pharmacotherapy of heart failure

Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open

Next steps

Brief summary (registry, in English)

The primary objective of the CT is to determine whether and how the serum concentrations of the listed medicinal products, including their metabolites, correlate with selected clinical indicators of heart failure.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
100 (estimated)
First submitted
10 Aug 2023
Start date
9 Apr 2024
Lead sponsor
Fakultni Nemocnice Ostrava
EU CT number
2023-506283-13-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 100
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - concurrent intravenous treatment with verapamil or diltiazem
  • Additional exclusion criteria for patients using Sacubitril/Valsartan - concomitant use with ACE inhibitors
  • Additional exclusion criteria for patients using Sacubitril/Valsartan - angioedema related to previous ACE inhibitor treatment or a history of ARB treatment

Other illness

  • Hypersensitivity to the medicinal substance or to any auxiliary substance
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - sinus node dysfunction syndrome (including sinoatrial block)
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Prinzmetal angina
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - severe peripheral arterial circulation disorders
  • Additional exclusion criteria for patients using Spironolactone - acute renal failure
  • Additional exclusion criteria for patients using Spironolactone - severe renal impairment (estimated glomerular filtration rate <10 ml/min)
  • Additional exclusion criteria for patients using Spironolactone - Addison's disease
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Unstable or decompensated heart failure belonging to the NYHA IV group according to the New York Heart Association classification, requiring intravenous inotropic support
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - History of bronchospasm or asthma
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Severe obstructive airways disease
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - severe bradycardia (heart rate <50)

Lab values

  • Additional exclusion criteria for patients using Spironolactone - hyperkalemia >5.5 mmol/l
  • Additional exclusion criteria for patients using Spironolactone - hyponatremia <125 mmol/l
  • Additional exclusion criteria for patients using Spironolactone - concurrent use of eplerenone or other potassium-sparing diuretics
  • Additional exclusion criteria for patients using Sacubitril/Valsartan - concomitant use with medicinal products containing Aliskiren in patients with diabetes mellitus or in patients with impaired renal function (eGFR <60 ml/min/1.73 m2)

Other

  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - severe hypotension (systolic blood pressure <85 mmHg)
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - untreated pheochromocytoma
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - metabolic acidosis
  • Additional exclusion criteria for patients using Spironolactone - anuria
  • Pregnant and breastfeeding women
  • Additional exclusion criteria for patients using Spironolactone - porphyria
  • Additional exclusion criteria for patients using Sacubitril/Valsartan - hereditary or idiopathic angioedema
  • Additional exclusion criteria for patients using Sacubitril/Valsartan - severe liver dysfunction, biliary cirrhosis and cholestasis
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - Clinically manifest liver dysfunction
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - 2nd and 3rd degree A-V block (unless a permanent pacemaker is implanted)
  • Additional exclusion criteria for patients using Bisoprolol, Carvedilol, Metoprolol succinate or Nebivolol - cardiogenic shock

Who the study is looking for

  • HFrEF with already established or newly started treatment with the listed medicinal products
  • Male and female patients over 18 years of age
  • Signed Informed Consent with participation in the study
  • Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) result at the initial visit and use an acceptable method of contraception with a home control urine pregnancy test every 3 months throughout the duration of the study

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fakultni Nemocnice OstravaPorubaCzechiaRecruiting

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