Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation

Not Applicable

Terminated

• Conditions: Heart Failure
• Interventions: Device: Conductance catheter

• Registration Number: NCT02751853
• Lead Sponsor: University of Luebeck

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-26
• Study Start: 2016-12
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No HFPEF/HFREF	Conductance catheter	Patient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF)
HFPEF	Conductance catheter	Patient with heart failure with preserved ejection fraction (HFPEF)
HFREF	Conductance catheter	Patient with heart failure with reduced ejection fraction (HFREF)

Primary Outcome Measures

Name	Time	Method
Hemodynamic parameter 1: Changes in contractility assessed by the end-systolic pressure-volume relationship	Day 1	Changes in contractility after handgrip exercise assessed by the end-systolic pressure-volume relationship

Secondary Outcome Measures

Name	Time	Method
Hemodynamic parameter 3: Changes in relaxation assessed by the relaxation constant "tau"	Day 1	Changes in relaxation after handgrip exercise assessed by the relaxation constant "tau"
Hemodynamic parameter 2: Changes in contractility assessed by the peak power index	Day 1	Changes in contractility after handgrip exercise assessed by the peak power index
Functional parameter: Changes in ejection fraction	Day 1	Changes in ejection fraction after handgrip exercise assessed by echocardiography

Trial Locations

Locations (1)

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany