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NCT04694092: LARISA
Landiolol for Rate Control in Decompensated Heart Failure Due to Atrial Fibrillation
NA trial testing Intensive heart rate control with landiolol in Atrial Fibrillation in 40 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Institute for Clinical and Experimental Medicine |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 5 November 2020 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- Intensive heart rate control with landiolol — full drug profile →
- Standard approach to heart rate control — full drug profile →
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Atrial Fibrillation Rapid — all drugs for Atrial Fibrillation Rapid →
- Acute Heart Failure — all drugs for Acute Heart Failure →
- Left Ventricular Dysfunction — all drugs for Left Ventricular Dysfunction →
Sponsor
Institute for Clinical and Experimental Medicine
Who can join
18 and older, any sex, with Atrial Fibrillation or Atrial Fibrillation Rapid. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study will include patients with acute heart failure with reduced left ventricular ejection fraction (\<40%) triggered by atrial fibrillation (AF) with a heart rate of \>130/min. Patients in cardiogenic shock, critical state, or patients requiring emergent electric cardioversion during the first 2 hours will be excluded. The patients will be randomized (1:1) to a strategy of initial intensive heart rate control using continuous infusion of landiolol and boluses of digoxin vs. standard approach to the rate control without the use of landiolol. All patients will receive recommended pharmacotherapy of acute heart failure (diuretics, nitrates, inotropes in patients with signs of low cardiac output - preferentially milrinone or levosimendan). The patients will undergo hemodynamic monitoring, laboratory testing, evaluation of symptoms, and quantification of lung water content by ultrasound for 48 hours. The study will test a hypothesis whether patients treated with initial intensive heart rate control with the preferential use of landiolol will achieve faster heart rate control, compensation of heart failure, and relief of heart failure symptoms without causing hypotension or deterioration of heart failure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04694092
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04694092 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute for Clinical and Experimental Medicine
- Last refreshed: 6 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04694092.
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