MedPath

Dopamine on top of standard treatment for patients with exacerbation of Heart Failure, at home situatio

Phase 1
Conditions
exacerbation of Heart Failure treated at home
MedDRA version: 13.1Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 13.1Level: LLTClassification code 10019284Term: Heart failure, congestiveSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 13.1Level: LLTClassification code 10024106Term: Left heart failureSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 13.1Level: LLTClassification code 10064082Term: Heart failure NYHA class IVSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 13.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 13.1Level: LLTClassification code 10064653Term: Acute decompensated heart failureSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2011-002236-92-NL
Lead Sponsor
Maatschap cardiologie Isala klinieken Zwolle
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
110
Inclusion Criteria

Exacerbation heart failure with NYHA class III-IV
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

•Cardiogenic shock
•Tachycardia, heart rate > 100 bpm
•Indication for hospitalization
•Severe aortic valve stenosis
•Severe hepatic or renal disease
•Patients with acute coronary syndromes
•Previous participation in the study
•Life expectancy of < 1 year
•Absolute contra indication for the use of Dopamine
•Women of child-bearing potential
•Unable to provide informed consent

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath