VASODILATATION OR LOOP-DIURETICS FOR INITIAL TREATMENT OF PULMONARY CONGESTION DUE TO ACUTE HEART FAILURE – A RANDOMIZED PLACEBO-CONTROLLED TRIA
Phase 1
Recruiting
- Conditions
- Acute heart failure with pulmonary congestionMedDRA version: 21.1Level: LLTClassification code: 10066733Term: Acute pulmonary congestion Class: 10038738MedDRA version: 20.0Level: LLTClassification code: 10000803Term: Acute heart failure Class: 10007541Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2022-500035-36-01
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1104
Inclusion Criteria
Age = 18 years, Acute (within minutes to days) onset or worsening of subjective dyspnea, Systolic blood pressure =100 mmHg, Oxygen saturation <94% or need of oxygen, Clinical signs or suspicion of congestion (peripheral edema, rales, and/or clinical suspicion of congestion)
Exclusion Criteria
More than 40 mg IV furosemide within the last three hours before randomization including prehospital treatment., More than 3 hours from hospital-admission to randomization., Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR > 180 or < 40 bpm., Suspected severe infection or sepsis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method