Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation

Heart Failure Clinical Trial

— ANREP-EF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02751853
• Other study ID #: 16-011
• Status: Terminated
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Conductance catheter
Continuous online measurements of left ventricular pressure and volume using conductance catheters

Locations

Country	Name	City	State
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Functional parameter: Changes in ejection fraction	Changes in ejection fraction after handgrip exercise assessed by echocardiography	Day 1