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FAST PV and mGFR™ Technology in Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808948
Recruitment Status : Completed
First Posted : January 18, 2019
Results First Posted : November 17, 2021
Last Update Posted : November 17, 2021
Sponsor:
Collaborator:
FAST BioMedical
Information provided by (Responsible Party):
Kai Schmidt-Ott, Charite University, Berlin, Germany

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition CHF
Intervention Device: VFI
Enrollment 50
Recruitment Details A totally of 50 hospitalized patients were enrolled between January 10th, 2019 and August 15th, 2019.
Pre-assignment Details No patients were excluded after enrollment but before assignment to the treatment group.
Arm/Group Title All Patients
Hide Arm/Group Description

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Period Title: Overall Study
Started 50
Completed 50
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
72.5  (13.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
10
  20.0%
Male
40
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
48
  96.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 50 participants
50
Weight day 1 (kg)  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 50 participants
89.21  (22.24)
Height day 1 (cm)  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 50 participants
172.84  (10.62)
BMI day 1 (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kilograms / meter squared
Number Analyzed 50 participants
29.7  (6)
1.Primary Outcome
Title Number of Participants With Treatment Related AEs and Serious Adverse Events (SAEs)
Hide Description The percentage of treatment emergent SAEs considered to be surely related to the VFI should be zero.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Percentage Difference in Mean Plasma Concentration of FD003 Over the 15-, 30-, and 60-minute Blood Draws on Days 1 and 3
Hide Description

Function of the FAST PV measurement will be assessed by determining the plasma stability of the FD003 high molecular weight marker over the 15, 30, and 60 minute blood draws and applying the following criteria:

  • The FAST PV measurement is considered as stable, if the mean plasma concentration of FD003 at 30 minutes is not more than 10% lower than the mean plasma concentration at 15 minutes AND if the mean plasma concentration at 60 minutes is not more than 10% lower than the mean plasma concentration at 30 minutes
  • We will determine the percentage of patients which show a decline in the plasma concentration of FD003 of more than 10% from 15min to 30min and separately from 30 min to 60min. This percentage should be ideally close to 0.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Percent difference, plasma concentration
Difference between Day 1 mean plasma concentration of FD003 at 15 minutes and 30 minutes -2.36  (7.94)
Difference between Day 3 mean plasma concentration of FD003 at 15 minutes and 30 minutes -3.12  (11.29)
% difference between Day 1 mean plasma concentration of FD003 at 30 minutes and 60 minutes -0.8  (5.6)
% difference between Day 3 mean plasma concentration of FD003 at 30 minutes and 60 minutes -0.79  (8.67)
3.Secondary Outcome
Title Accuracy Between Estimated PV (ePV) on Days 1 and 3 (by Established Measures) and Measured PV (mPV; as Assessed by FAST Methodology) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Hide Description The percentage difference between ePV and mPV were evaluated to consider the percentage of the population with a <15% and <30% difference between ePV and mPV on day 1 and day 3
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not have a hematocrit available for ePV determination, fourteen patients did not have day 3 measurements of mPV.
Arm/Group Title All Patients
Hide Arm/Group Description:

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Overall Number of Participants Analyzed 49
Measure Type: Count of Participants
Unit of Measure: Participants
Number patients where ePV (Kaplan Hakim) was within 15% of mPV day1 Number Analyzed 49 participants
32
  65.3%
Number patients where ePV (Kaplan Hakim) was within 30% of mPV day 1 Number Analyzed 49 participants
44
  89.8%
Number patients where ePV (Kaplan Hakim) was within 15% of mPV day3 Number Analyzed 36 participants
24
  66.7%
Number patients where ePV (Kaplan Hakim) was within 30% of mPV day3 Number Analyzed 36 participants
30
  83.3%
4.Secondary Outcome
Title Accuracy Between Estimated Total Blood Volume (TBV) on Days 1 and 3 and Measured TBV (mTBV; Calculated From mPV and Measured Hematocrit) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Hide Description Accuracy between the Nadler's Formula as an estimate of total blood volume (TBV) and measured blood volume (mTBV) on days 1 and 3 as determined by the percentage of the population with a <15% and <30% difference between ePV and mPV
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not have a hematocrit on day 1 for calculation of mTBV and eTBV, twelve patients did not receive a second measurement on day 3, two patients that recieved a second measurement, did not have a hematocrit on day 3 for calculation of mTBV and eTBV
Arm/Group Title All Patients
Hide Arm/Group Description:

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Overall Number of Participants Analyzed 49
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients where eTBV was within 15% of mTBV value day1 Number Analyzed 49 participants
32
  65.3%
Number of patients where eTBV was within 30% of mTBV value day1 Number Analyzed 49 participants
45
  91.8%
Number of patients where eTBV was within 15% of mTBV value day3 Number Analyzed 36 participants
25
  69.4%
Number of patients where eTBV was within 30% of mTBV value day3 Number Analyzed 36 participants
32
  88.9%
5.Secondary Outcome
Title Accuracy of eGFR Determined by CKD-EPI-SCr and mGFR on Day 1 and Day 3 Defined the Percentage of the Population With a <15% and <30% Difference Between eGFR and mGFR
Hide Description To evaluate whether estimated Glomerular Filtration Rate (eGFR) (calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) on days 1 and 3 provides an accurate estimate of measured GFR (mGFR; assessed by FAST methodology) in heart failure patients under-going active fluid management, determined by the percentage of patients with a <15% and <30% difference between eGFR and mGFR
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
twelve patients did not have mGFR measurement on day 3, so only 38 patients are analyzed on day 3
Arm/Group Title All Patients
Hide Arm/Group Description:

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients where eGFR was within 15% of mGFR value on Day 1. Number Analyzed 50 participants
20
  40.0%
Number of patients where eGFR was within 15% of mGFR value on Day 3. Number Analyzed 38 participants
10
  26.3%
Number of patients where eGFR was within 30% of mGFR value on Day 1. Number Analyzed 50 participants
33
  66.0%
Number of patients where eGFR was within 30% of mGFR value on Day 3. Number Analyzed 38 participants
24
  63.2%
6.Secondary Outcome
Title Percentage of the Population That Developed Acute Kidney Injury (AKI) Within the Following 48-72 Hour and Prediction of AKI by mGFR/eGFR Ratio on Days 1 and 3
Hide Description To evaluate the percentage of patients developing acute kidney injury (AKI) within the following 48-72 hours on day 1 and day 3 and to evaluate whether patients with a low mGFR/eGFR ratio on days 1 and 3 are at higher risk of developing acute kidney injury (AKI) within the following 48-72 hours using a binary logisitic regression with AKI as binary outcome and mGFR/eGFR as independent variate
Time Frame 48-72h
Hide Outcome Measure Data
Hide Analysis Population Description
36 patients had data for AKI determination 48h after day 1, 32 patients had data for AKI determination after day 3
Arm/Group Title All Patients
Hide Arm/Group Description:

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
Number of patients with AKI within 48h after day 1 Number Analyzed 36 participants
17
  47.2%
Number of patients with AKI within 48h after day 3 Number Analyzed 32 participants
11
  34.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Patients
Comments Binary logistic regression with mGFR/eGFR ratio as independent variate, AKI as binary outcome
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4842
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.08 to 1.97
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Patients Who Are Refractory to Diuretic Therapy
Hide Description Being refractory to diuretic therapy (defined as any dosage increases of furosemide i.v. dose equivalent, adding thiazide after day 1, requirement of ultrafiltration/RRT within the next 24-48 hours, failure to improve subjectively in PGA and dyspnoea scales, failure of mean weight loss during the study period Day 1-Day 5 of at least 0,5 kg/d).
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
one patient did not have weight data, two patients were discharged after first measurement (day 1) so no lineary observation was possible
Arm/Group Title All Patients
Hide Arm/Group Description:

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Overall Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
Not refractory to diuretics
7
  14.9%
Refractory to diuretics
40
  85.1%
8.Secondary Outcome
Title Percentage of Population in Which Clinical Decision Making Would Have Been Influenced by Adding FAST GFR and PV Measurements to Clinical Routine Determined by Survey Response (by an Adjudication Committee)
Hide Description Percentage of patients for whom the data decision committee decided to increase or decrease the dose of diuretics, guideline-directed medical therapy (GDMT), beta-blockers, or RAAS inhibitors from the dose indicated by the treating physician after considering the mPV/mTBV determined using FAST BioMedical technology.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
Number or patients where adjudication committee would have changed diuretic dose
40
  80.0%
Number or patients where adjudication committee would have changed RAASi dose
5
  10.0%
Number or patients where adjudication committee would have changed beta blocker dose
6
  12.0%
Number or patients where adjudication committee would have changed GDMT
1
   2.0%
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description

VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous

VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.

All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   1/50 (2.00%) 
Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   21/50 (42.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/50 (2.00%) 
Cardiac disorders   
cardiac failure  1  3/50 (6.00%) 
Atrial fibrillation  1  1/50 (2.00%) 
Gastrointestinal disorders   
Thrombosis mesenteric vessel  1  1/50 (2.00%) 
General disorders   
Multiple organ dysfunction syndrome  1  1/50 (2.00%) 
Infections and infestations   
Pneumonia  1  3/50 (6.00%) 
Endocarditis  1  2/50 (4.00%) 
Infectious pleural effusion  1  1/50 (2.00%) 
Urosepsis  1  1/50 (2.00%) 
Injury, poisoning and procedural complications   
Anaemia postoperative  1  1/50 (2.00%) 
Lumbar vertebral fracture  1  1/50 (2.00%) 
Post procedural fistula  1  1/50 (2.00%) 
Post procedural haemorrhage  1  1/50 (2.00%) 
Postoperative delirium  1  1/50 (2.00%) 
Investigations   
Troponin increased  1  1/50 (2.00%) 
Metabolism and nutrition disorders   
Fluid overload  1  1/50 (2.00%) 
Nervous system disorders   
Cerebral infarction  1  1/50 (2.00%) 
Syncope  1  1/50 (2.00%) 
Renal and urinary disorders   
Acute kidney Injury  1  3/50 (6.00%) 
Azotaemia  1  1/50 (2.00%) 
Vascular disorders   
Hypertensive crisis  1  1/50 (2.00%) 
Ischaemia  1  1/50 (2.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients
Affected / at Risk (%)
Total   37/50 (74.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/50 (2.00%) 
Splenomegaly  1  1/50 (2.00%) 
Cardiac disorders   
Cardiac failure  1  3/50 (6.00%) 
Atrial fibrillation  1  1/50 (2.00%) 
Arrhythmia  1  1/50 (2.00%) 
Coronary artery disease  1  1/50 (2.00%) 
Tachycardia  1  1/50 (2.00%) 
Congenital, familial and genetic disorders   
Phimosis  1  1/50 (2.00%) 
Ear and labyrinth disorders   
Vertigo  1  1/50 (2.00%) 
Gastrointestinal disorders   
Diarrhoea  1  6/50 (12.00%) 
Constipation  1  2/50 (4.00%) 
Nausea  1  2/50 (4.00%) 
Abdominal pain lower  1  1/50 (2.00%) 
Colitis  1  1/50 (2.00%) 
Duodenal ulcer  1  1/50 (2.00%) 
Erosive oesophagitis  1  1/50 (2.00%) 
Gastritis  1  1/50 (2.00%) 
Gastrointestinal angiodysplasia  1  1/50 (2.00%) 
Haemorrhoids  1  1/50 (2.00%) 
Intestinal polyp  1  1/50 (2.00%) 
Large intestine polyp  1  1/50 (2.00%) 
Melaena  1  1/50 (2.00%) 
Subileus  1  1/50 (2.00%) 
Thrombosis mesenteric vessel  1  1/50 (2.00%) 
Varices oesophageal  1  1/50 (2.00%) 
Vomiting  1  1/50 (2.00%) 
General disorders   
Pyrexia  1  3/50 (6.00%) 
Chest pain  1  1/50 (2.00%) 
Asthenia  1  1/50 (2.00%) 
Fatigue  1  1/50 (2.00%) 
Gait disturbance  1  1/50 (2.00%) 
Multiple organ dysfunction syndrome  1  1/50 (2.00%) 
Pain  1  1/50 (2.00%) 
Xerosis  1  1/50 (2.00%) 
Hepatobiliary disorders   
Cholelithiasis  1  1/50 (2.00%) 
Immune system disorders   
Drug hypersensitivity  1  2/50 (4.00%) 
Hypersensitivity  1  1/50 (2.00%) 
Infections and infestations   
Pneumonia  1  6/50 (12.00%) 
Endocarditis  1  2/50 (4.00%) 
Urinary tract infection  1  2/50 (4.00%) 
Device related infection  1  1/50 (2.00%) 
Gastroenteritis  1  1/50 (2.00%) 
Gastroenteritis rotavirus  1  1/50 (2.00%) 
Infectious pleural effusion  1  1/50 (2.00%) 
Nasopharyngitis  1  1/50 (2.00%) 
Oesophageal candidiasis  1  1/50 (2.00%) 
Upper respiratory tract infection  1  1/50 (2.00%) 
Urosepsis  1  1/50 (2.00%) 
Injury, poisoning and procedural complications   
Fall  1  3/50 (6.00%) 
Anaemia postoperative  1  1/50 (2.00%) 
Lumbar vertebral fracture  1  1/50 (2.00%) 
Post procedural fever  1  1/50 (2.00%) 
Post procedural fistula  1  1/50 (2.00%) 
Post procedural haematuria  1  1/50 (2.00%) 
Post procedural haemorrhage  1  1/50 (2.00%) 
Postoperative delirium  1  1/50 (2.00%) 
Procedural pain  1  1/50 (2.00%) 
Wound  1  1/50 (2.00%) 
Investigations   
Aspartate aminotransferase increased  1  3/50 (6.00%) 
Troponin increased  1  2/50 (4.00%) 
Bilirubin conjugated increased  1  2/50 (4.00%) 
C-reactive protein increased  1  2/50 (4.00%) 
Gamma-glutamyltransferase increased  1  2/50 (4.00%) 
Blood alkaline phosphatase increased  1  1/50 (2.00%) 
Blood bilirubin increased  1  1/50 (2.00%) 
Blood creatine phosphokinase abnormal  1  1/50 (2.00%) 
Blood creatinine increased  1  1/50 (2.00%) 
Brain natriuretic peptide increased  1  1/50 (2.00%) 
Procalcitonin abnormal  1  1/50 (2.00%) 
Procalcitonin increased  1  1/50 (2.00%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  4/50 (8.00%) 
Decreased appetite  1  2/50 (4.00%) 
Hyperkalaemia  1  2/50 (4.00%) 
Electrolyte imbalance  1  1/50 (2.00%) 
Fluid overload  1  1/50 (2.00%) 
Hyperglycaemia  1  1/50 (2.00%) 
Hypernatraemia  1  1/50 (2.00%) 
Hyperphosphataemia  1  1/50 (2.00%) 
Hypertriglyceridaemia  1  1/50 (2.00%) 
Hyperuricaemia  1  1/50 (2.00%) 
Hypoalbuminaemia  1  1/50 (2.00%) 
Hypoproteinaemia  1  1/50 (2.00%) 
Iron deficiency  1  1/50 (2.00%) 
Metabolic acidosis  1  1/50 (2.00%) 
Vitamin D deficiency  1  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  2/50 (4.00%) 
Joint swelling  1  2/50 (4.00%) 
Muscle spasms  1  2/50 (4.00%) 
Muscular weakness  1  1/50 (2.00%) 
Musculoskeletal pain  1  1/50 (2.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon adenoma  1  1/50 (2.00%) 
Lung neoplasm  1  1/50 (2.00%) 
Nervous system disorders   
Syncope  1  2/50 (4.00%) 
Cerebral infarction  1  1/50 (2.00%) 
Dementia Alzheimer's type  1  1/50 (2.00%) 
Dizziness  1  1/50 (2.00%) 
Headache  1  1/50 (2.00%) 
Partial seizures  1  1/50 (2.00%) 
Psychiatric disorders   
Sleep disorder  1  5/50 (10.00%) 
Delirium  1  1/50 (2.00%) 
Depressed mood  1  1/50 (2.00%) 
Disorientation  1  1/50 (2.00%) 
Renal and urinary disorders   
Acute kidney injury  1  5/50 (10.00%) 
Azotaemia  1  1/50 (2.00%) 
End stage renal disease  1  1/50 (2.00%) 
Urinary tract obstruction  1  1/50 (2.00%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  2/50 (4.00%) 
Penile haemorrhage  1  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  3/50 (6.00%) 
Cough  1  1/50 (2.00%) 
Diaphragmatic disorder  1  1/50 (2.00%) 
Epistaxis  1  1/50 (2.00%) 
Painful respiration  1  1/50 (2.00%) 
Pleural effusion  1  1/50 (2.00%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  3/50 (6.00%) 
Skin disorder  1  1/50 (2.00%) 
Social circumstances   
Immobile  1  1/50 (2.00%) 
Surgical and medical procedures   
Coronary arterial stent insertion  1  1/50 (2.00%) 
Vascular disorders   
Hypotension  1  2/50 (4.00%) 
Hypertensive crisis  1  1/50 (2.00%) 
Ischaemia  1  1/50 (2.00%) 
Thrombophlebitis  1  1/50 (2.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. med. Kai Schmidt-Ott
Organization: Charité - Universitätsmedizin Berlin
Phone: +4930450614671
EMail: Kai.schmidt-ott@charite.de
Layout table for additonal information
Responsible Party: Kai Schmidt-Ott, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03808948    
Other Study ID Numbers: EmPaKt-CHF
2018-002638-18 ( EudraCT Number )
First Submitted: January 8, 2019
First Posted: January 18, 2019
Results First Submitted: July 28, 2021
Results First Posted: November 17, 2021
Last Update Posted: November 17, 2021