Gated 13N-NH3 PET before and during hemodialysis for the assessment of changes in myocardial perfusion, volumes and output of the left ventricle

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000867-27-NL

Enrollment

Registered

2006-03-29

Start date

2006-05-04

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Hemodialysis patients

Interventions

Trade Name: (13N)-NH3 Product Name: (13N)-NH3 Product Code: n.a. Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Ammonia CAS Number: 7664-41-7 Current Sponsor code: n.a. Other descript

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult (age above 18) HD patients who have been treated with HD for at least six months. Patients must have an arterio-venous fistula without recirculation established by Transonic flow measurements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. The absence of informed consent (see ethical considerations) 2. The need to perform HD with pre-dilution. 3. Recent haemorrhage. 4. Unstable angina pectoris. 5. History of myocardial infarction. 6. Inability to endure a horizontal position for a longer period of time. 7. Arrhythmia. 8. The use of long-acting nitrates. 9. Left ventricular ejection fraction = 30%. 10. Diabetes Mellitus. 11. Pregnancy or suspicion hereof.

Design outcomes

Primary

Measure	Time frame
Main Objective: In this study we propose to evaluate first; the technical and logistical feasibility of measuring changes in myocardial perfusion and left ventricular function with gated 13N-NH3 PET before and during HD. Second: to study changes in myocardial perfusion and left ventricular function before and during hemodialysis. ;Secondary Objective: ;Primary end point(s): The outcome parameters are changes in cardiac output, myocardial contractility, left ventricular ejection fraction, left ventricular diameter, left ventricular end-systolic volume, left ventricular end-diastolic volume, left ventricular myocardial perfusion in ml/min/g and regional wall motions. Data will be analysed quantitatively and displayed in a 17-segment polar map as recently proposed. Each individual session will be evaluated for pre- and post-study body weight, total ultrafiltration volume, blood pressure and the course of relative blood volume (measured non-invasively by an RBV monitor) throughout the study.	—

Measure

Time frame

Main Objective: In this study we propose to evaluate first; the technical and logistical feasibility of measuring changes in myocardial perfusion and left ventricular function with gated 13N-NH3 PET before and during HD. Second: to study changes in myocardial perfusion and left ventricular function before and during hemodialysis. ;Secondary Objective: ;Primary end point(s): The outcome parameters are changes in cardiac output, myocardial contractility, left ventricular ejection fraction, left ventricular diameter, left ventricular end-systolic volume, left ventricular end-diastolic volume, left ventricular myocardial perfusion in ml/min/g and regional wall motions. Data will be analysed quantitatively and displayed in a 17-segment polar map as recently proposed. Each individual session will be evaluated for pre- and post-study body weight, total ultrafiltration volume, blood pressure and the course of relative blood volume (measured non-invasively by an RBV monitor) throughout the study.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026