Not Authorised Therapeutic exploratory (Phase II) Acute Heart Failure

AP01 Heart Failure (AHF) Study

EU CTIS ID: 2023-507573-17-01

What this study is testing

Metabolism of the cardiomyocytes: a) Reduction of lactate during 90 minutes after first dose (AUC) b) Reduction of NT- proBNP after 72 hours

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Provide written informed consent according to local regulations. 2. Males and females aged > 18 years. 3. Unplanned hospitalization or emergency department visit for AHF. Acute HF is defined as including all of the following criteria: • Dyspnoea at rest in a recumbent sitting position (30 to 45 degrees), which has worsened within the past week. • Radiological evidence of HF on a chest X-ray (if an appropriate chest computerized tomography scan is done the X-ray need not be performed). • Brain natriuretic peptide (BNP) >500 pg/mL or NT-pro BNP >2000 pg/mL. 4. Serum lactate level above or equal to 18.0 mg/dl (≥ 1.99 mmol/L). 5. Ejection Fraction (EF) < 40% (echocardiography). 6. Ability to start the study drug administration within 12 h after initial clinical assessment. 7. Systolic blood pressure ≥ 90 mmHg and ≤ 165 mmHg at the time of initial clinical assessment.

You likely can't join if

  • 1. Women of child-bearing potential (i.e., pre-menopausal women) and breast-feeding women without documentation of a negative blood pregnancy assay within 12 h prior to randomization. 2. Patients with Heart Failure NYHA I and II. 3. Known active myocarditis, obstructive hypertrophic cardiomyopathy, congenital heart disease, restrictive cardiomyopathy, constrictive pericarditis, uncorrected clinically significant primary valvular disease. 4. Serum lactate level below 18.0 mg/dl < 1.99 mmol/L. 5. Clinical diagnosis of acute coronary syndrome meeting any 2 of the following 3 criteria: • Prolonged chest pain at rest, or an accelerated pattern of angina • Electrocardiogram changes indicative of ischemia or myocardial injury defined as: a new ST elevation at the J point of two anatomically contiguous leads with the cut-off points: ≥0.2 mV in men ≥40 years (>0.25 mV in men <40 years) or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads; or ST depression and T wave changes. New horizontal or down sloping ST depression ≥0.05 mV in two contiguous leads; and/or new T inversion ≥0.3 mV in two contiguous leads. • Serum troponin >3 times upper limit of normal. 6. Terminal illness other than congestive HF with expected survival <180 days. 7. Clinically suspected acute mechanical cause of ADHF (e.g., papillary muscular rupture). The diagnosis need not be confirmed by imaging or cardiac catheterization. 8. Body temperature ≥ 38°C just prior to randomization. 9. Acute or chronic respiratory disorder (e.g., severe chronic obstructive pulmonary disease) or primary pulmonary hypertension sufficient to cause dyspnea at rest, which may interfere with the ability to interpret dyspnea assessments or hemodynamic measurements. 10. Creatinine clearance <25 mL/min/1.73m² (as measured by the MDRD formula) at the time of screening. 11. Anemia (hemoglobin <9 g/dL or a hematocrit <25%) 12. Patients with severe hepatic impairment. 13. Current drug abuse or chronic alcoholism sufficient to impair participation and compliance to the study protocol. 14. Known vasculitis, active infective endocarditis, or suspected infections, e.g., pneumonia, acute hepatitis, systemic inflammatory syndrome, or sepsis. 15. Participation in an investigational clinical drug study within 30 days prior to randomization. 16. Males and females aged < 18 years. 17. Missing informed consent. 18. Any condition that, in the Investigator's opinion, makes the patient unsuitable for study participation.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.