Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation

Study Overview
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Brief Summary
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Aim of the study is to assess the effects of abruptly increased afterload on left ventricular contractility and relaxation in patients with heart failure with preserved ejection fraction (HFPEF), patients with heart failure with reduced ejection fraction (HFREF), and patients without HFPEF or HFREF.

Official Title
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Effects of Acutely Elevated Afterload oN Left VentRicular Contractility and RElaxation in Heart Failure With Preserved and Reduced Ejection Fraction

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Conductance catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical indication for left and right heart catheterization HFPEF (Group 1) OR HFREF (Group 2) OR absent echocardiographic evidence of HFREF OR HFPEF(Group 3) AND Sinus rhythm during invasive measurements Age ≥18 years Negative pregnancy test in women with childbearing potential Written informed consent Exclusion Criteria: Acute coronary syndrome Acute myocardial infarction <6 months Planned cardiac surgery or cardiovascular intervention within 6 months following inclusion Valvular heart disease >2° Severe comorbidities with limited life expectancy <12 months Precapillary pulmonary hypertension Participation in another trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFPEF<br>Patient with heart failure with preserved ejection fraction (HFPEF) | Device: Conductance catheter<br>* Continuous online measurements of left ventricular pressure and volume using conductance catheters<br>|
| Experimental: HFREF<br>Patient with heart failure with reduced ejection fraction (HFREF) | Device: Conductance catheter<br>* Continuous online measurements of left ventricular pressure and volume using conductance catheters<br>|
| Active Comparator: No HFPEF/HFREF<br>Patient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF) | Device: Conductance catheter<br>* Continuous online measurements of left ventricular pressure and volume using conductance catheters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic parameter 1: Changes in contractility assessed by the end-systolic pressure-volume relationship | Changes in contractility after handgrip exercise assessed by the end-systolic pressure-volume relationship | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic parameter 2: Changes in contractility assessed by the peak power index | Changes in contractility after handgrip exercise assessed by the peak power index | Day 1 | 
| Hemodynamic parameter 3: Changes in relaxation assessed by the relaxation constant tau | Changes in relaxation after handgrip exercise assessed by the relaxation constant tau | Day 1 | 
| Functional parameter: Changes in ejection fraction | Changes in ejection fraction after handgrip exercise assessed by echocardiography | Day 1 |