AP-01 i.v. as add-on treatment for acute heart failure NYHA ≥ III A mono-center, randomized double-blind, placebo-controlled study AP-01 Heart Failure (AHF) Study

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507573-17-01

Acronym

AP01-201

Enrollment

Registered

2024-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure

Brief summary

Reduction of lactate during 90 minutes after first dose, reported as area under the curve. Reduction of NT-proBNP 72 hours after first dose.

Detailed description

Symptomatic and clinical improvement: a) Echocardiography (Visit 1 compared to Visit 6) b) Kansas City Cardiomyopathy Questionnaire (KCCQ-23): Visit 1 compared to Visit 10 and 11. Symptomatic and clinical improvement: Outcome differences NYHA III compared to NYHA IV, Duration of hospital stay, Mortality and Rate of Re-Hospitalisation

Interventions

DRUGG-STROPHANTHIN

DRUGThe placebo vial contains NaCl 0.9% and phosphate buffer ad 1ml corresponding to the IMP except API for intravenous administration. There are no visible differences in comparison to volume

DRUGseize

DRUGexterior

DRUGcolour etc. of the investigational product.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Reduction of lactate during 90 minutes after first dose, reported as area under the curve. Reduction of NT-proBNP 72 hours after first dose.	—

Secondary

Measure	Time frame
Symptomatic and clinical improvement: a) Echocardiography (Visit 1 compared to Visit 6) b) Kansas City Cardiomyopathy Questionnaire (KCCQ-23): Visit 1 compared to Visit 10 and 11. Symptomatic and clinical improvement: Outcome differences NYHA III compared to NYHA IV, Duration of hospital stay, Mortality and Rate of Re-Hospitalisation	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026