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
Similar Trials
Completed
Not Applicable
Heart failure with preserved ejection fraction determination by exercise ultrasonography follow-upHeart failure with preserved ejection fraction - Diastolic heart failure10019280NL-OMON51990niversitair Medisch Centrum Utrecht170
Completed
Not Applicable
Heart failure with preserved ejection fraction, early diagnosisNL-OMON29452Academisch Ziekenhuis Maastricht (azM) Health Foundation Limburg72
Recruiting
Phase 3
Regular eating of betel leaves beneficial in heart patientsCTRI/2023/12/060649Vishwaraj Hospital
Not yet recruiting
Unknown
A Pilot Randomized Trial Evaluating the Feasibility and Safety of a Polypill Implementation Strategy in Patients with Heart Failure with Reduced Ejection Fraction in South AsiaHeart failure with reduced ejection fractionSLCTR/2024/003Washington University in St. Louis
Completed
Not Applicable
Cardiac Resynchronisation Therapy Versus Rate-responsive Pacing in Heart Failure With Preserved Ejection FractionDiastolic Heart FailureNCT03338374Cardiff and Vale University Health Board10