Effects of Acutely Elevated Afterload on Left Ventricular Contractility and Relaxation (ANREP-EF)

U

University of Luebeck

Status

Terminated

Conditions

Heart Failure

Treatments

Device: Conductance catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT02751853
16-011

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 3 patient groups

HFPEF
Experimental group
Description:
Patient with heart failure with preserved ejection fraction (HFPEF)
Treatment:
Device: Conductance catheter
HFREF
Experimental group
Description:
Patient with heart failure with reduced ejection fraction (HFREF)
Treatment:
Device: Conductance catheter
No HFPEF/HFREF
Active Comparator group
Description:
Patient without heart failure with preserved ejection fraction (HFPEF) or heart failure with reduced ejection fraction (HFREF)
Treatment:
Device: Conductance catheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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