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Clinical Trials/EUCTR2007-004150-85-DE
EUCTR2007-004150-85-DEActive, not recruitingNot Applicable

Cardiac failure with normal ejection fraction: possible role of phosphodiesterase type 5 inhibitors - HINEF: PDE5

Charité Universitaetsmedizin Berlin0 sitesStarted: December 4, 2007Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • - accomplished patient information, and written informed consent of the patient
  • - age between 18 and 75
  • - at least 1 admission to the hospital with diagnosis cardiac insufficiency NYHA class II-IV in the past
  • - negative pregnancy test
  • - women of childbearing age only with highly effective contraception (defined as
  • PEARL-Index < 1 %)
  • - no participation in another driven study according to german drugs act (30 days before and during the trial)
  • - sufficient renal function (creatinin under 1,7 mg/dl)
  • - sufficient hepatic function (serum GOT, serum GPT under 60 U/l)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • - pregnancy and lactation
  • - women of childbearing age without highly effective contraception
  • - coronary heart disease with significant stenosis after implantation of a coronary stent
  • - cardiac valve diseases higher than class I (aortic, mitral and tricuspidic)
  • - hypersensitivity to contrast substance
  • - acute apoplexy
  • - arterial hypotension (below 90/50 of Hg)
  • - neoplasmatic diseases with expected survival < 18 months
  • - nonarteritic anterior ischemic optic neuropathy (NAION)
  • - simultaneous taking of No donators, alpha blockers and/or other PDE-5 inhibitors (Viagra, Cialis)
  • - hepatic insufficiency (CHILD PHUG C)
  • - renal insufficiency requiring dialysis
  • - cardiac infarction or apoplexis during the last 6 months
  • - retinitis pigmentosa
  • - simultaneous taking of itraconazole/ketoconazole
  • - HIV infection and/or taking of HIV protease inhibitors
  • - active hepatitis A/B
  • - hypersensitivity against vardenafil
  • - Persons who are detained officially or legally to an official institute (e.g. psychiatric
  • institute or prison)
  • - missing willingness to storaging and transferring pseudonymous disease data within this study
  • - missing willingness to cooperate

Investigators

Sponsor
Charité Universitaetsmedizin Berlin

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