Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318260
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-12
Brief Title:
Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy ATTRwt
Sponsor:
Steen Hvitfeldt Poulsen
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy ATTRwt
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DobATTR
Brief Summary:
The goal of this clinical trial is to test the effects of the inotropic drug named dobutamine in patients with wild-type Transthyretin Amyoid Cardiomyopathy ATTRwt The main questions it aims to answer are
What are the effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt
Safety of dobutamine infusion in this patient population
Participants will be given increasing dosages of dobutamine infusion and its effect on cardiac output and filling pressures will be assessed non-invasively by echocardiography and invasively by right heart catheterization simultaneously
What are the effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt
Safety of dobutamine infusion in this patient population
Participants will be given increasing dosages of dobutamine infusion and its effect on cardiac output and filling pressures will be assessed non-invasively by echocardiography and invasively by right heart catheterization simultaneously
Detailed Description:
AIMS
To investigate the hemodynamic effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt assessed simultaneously by right heart catheterization RHC and echocardiography
To assess the safety of dobutamine infusion in ATTRwt patients
HYPOTHESIS
Dobutamine infusion can increase myocardial contractility in patients with symptomatic ATTRwt with an increase of CO by 10
The left ventricular filling pressure as expressed by the pulmonary artery wedge pressure PAWP andor mean pulmonary artery pressure mPAP will decrease by 10 during increasing dobutamine dosages
Dobutamine is well-tolerated and safe to use in symptomatic ATTRwt patients
MATERIALS AND METHODS
Study population Symptomatic participants with ATTRwt age 65 years who have reduced left ventricular ejection fraction LVEF andor stroke volume index SVI without significant valvular diseases or severe coronary artery diseases
Study design
Eligible patients will be assessed in the trial day one day as following
Step1 Baseline assessment Blood pressure pulse and ECG will be obtained All participants will also undergo a comprehensive resting transthoracic echocardiographic assessment according to current guidelines
Step 2 Invasive right heart catheterization RHC The subjects will be instructed not to eat for 6 hours and not to drink for 2 hours before the procedure RHC will be performed in the cardiac invasive laboratory using right internal jugular vein access Rarely right femoral vein access will be used if the right internal jugular vein is difficult to canulate as a result of anatomical anomalies or local skin or muscle deformities A 7 Fr sheath will be inserted in the vein aseptic and ultrasound guided in local anaesthesia Subsequently a pulmonary catheter Swan-Ganz will be advanced through the sheath guided by pressure waves and fluoroscopy through the right atrium the right ventricle and ultimately in a stable position in the pulmonary artery PA The standard Swan-Ganz catheter is equipped with an inflatable balloon at the tip which facilitates its placement into the PA through the flow of blood The balloon when inflated causes the catheter to wedge in a small pulmonary blood vessel While wedged the catheter can provide an indirect measurement of the mean left atrium pressure Central oxygenation of the blood SvO2 and N-terminal pro-B-type natriuretic peptide NT-proBNP will be assessed from blood taken from the pulmonary artery at rest and at peak dobutamine infusion according to the protocol
The PA catheter location will be confirmed with fluoroscopy before leaving the laboratory and both the sheath and the catheter will be fixed to the skin
RHC is performed using a standard 7 Fr triple lumen Swan-Ganz catheter Edwards Lifesciences Irvine California USA
The following parameters will be measured by RHC
PAWP
Mean right atrial pressure
Systolic and diastolic PA pressure
mPAP
CO All pressures at rest are measured at end-expiration as the average of five measurements CO is measured using thermodilution methods as the average of at least four measurements not differing more than 10 and indexed to body surface area as the Cardiac Index CI SV is calculated as CO divided by heart rate
Step 3 Dobutamine challenge
Step 4 Recovery period The pulmonary catheter and sheath will be removed after a-5-minute recovery period right after obtaining the final images and invasive measurements The participants will be observed for 2 hours after the end of the test and will be discharged if no complications arise Blood sample will be taken to measure NT-proBNP after 1-2 hours after the end of dobutamine challenge
The investigators expect the study will last for about 6-7 hours including preparations waiting time the procedures themselves and the observation period
To investigate the hemodynamic effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt assessed simultaneously by right heart catheterization RHC and echocardiography
To assess the safety of dobutamine infusion in ATTRwt patients
HYPOTHESIS
Dobutamine infusion can increase myocardial contractility in patients with symptomatic ATTRwt with an increase of CO by 10
The left ventricular filling pressure as expressed by the pulmonary artery wedge pressure PAWP andor mean pulmonary artery pressure mPAP will decrease by 10 during increasing dobutamine dosages
Dobutamine is well-tolerated and safe to use in symptomatic ATTRwt patients
MATERIALS AND METHODS
Study population Symptomatic participants with ATTRwt age 65 years who have reduced left ventricular ejection fraction LVEF andor stroke volume index SVI without significant valvular diseases or severe coronary artery diseases
Study design
Eligible patients will be assessed in the trial day one day as following
Step1 Baseline assessment Blood pressure pulse and ECG will be obtained All participants will also undergo a comprehensive resting transthoracic echocardiographic assessment according to current guidelines
Step 2 Invasive right heart catheterization RHC The subjects will be instructed not to eat for 6 hours and not to drink for 2 hours before the procedure RHC will be performed in the cardiac invasive laboratory using right internal jugular vein access Rarely right femoral vein access will be used if the right internal jugular vein is difficult to canulate as a result of anatomical anomalies or local skin or muscle deformities A 7 Fr sheath will be inserted in the vein aseptic and ultrasound guided in local anaesthesia Subsequently a pulmonary catheter Swan-Ganz will be advanced through the sheath guided by pressure waves and fluoroscopy through the right atrium the right ventricle and ultimately in a stable position in the pulmonary artery PA The standard Swan-Ganz catheter is equipped with an inflatable balloon at the tip which facilitates its placement into the PA through the flow of blood The balloon when inflated causes the catheter to wedge in a small pulmonary blood vessel While wedged the catheter can provide an indirect measurement of the mean left atrium pressure Central oxygenation of the blood SvO2 and N-terminal pro-B-type natriuretic peptide NT-proBNP will be assessed from blood taken from the pulmonary artery at rest and at peak dobutamine infusion according to the protocol
The PA catheter location will be confirmed with fluoroscopy before leaving the laboratory and both the sheath and the catheter will be fixed to the skin
RHC is performed using a standard 7 Fr triple lumen Swan-Ganz catheter Edwards Lifesciences Irvine California USA
The following parameters will be measured by RHC
PAWP
Mean right atrial pressure
Systolic and diastolic PA pressure
mPAP
CO All pressures at rest are measured at end-expiration as the average of five measurements CO is measured using thermodilution methods as the average of at least four measurements not differing more than 10 and indexed to body surface area as the Cardiac Index CI SV is calculated as CO divided by heart rate
Step 3 Dobutamine challenge
Step 4 Recovery period The pulmonary catheter and sheath will be removed after a-5-minute recovery period right after obtaining the final images and invasive measurements The participants will be observed for 2 hours after the end of the test and will be discharged if no complications arise Blood sample will be taken to measure NT-proBNP after 1-2 hours after the end of dobutamine challenge
The investigators expect the study will last for about 6-7 hours including preparations waiting time the procedures themselves and the observation period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None