Study of efficacy and safety of diuretic administered with saline solution in the patient who presents decompensation of heart failure and does not require hospitalization.

Phase 1

• Conditions: Decompensated Heart Failure; MedDRA version: 20.0Level: LLTClassification code 10010684Term: Congestive heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-002852-17-ES
• Lead Sponsor: Marta Cobo Marcos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-06
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Age> 18 years
• Previous diagnosis of HF and stable treatment the previous 4 weeks (except diuretic).
• Basal treatment of at least 80 mg of furosemide daily.
• Transthoracic echocardiogram performed last year. All ejection fraction (EF) groups are included.
• Decompensated heart failure of congestive predominance. NTproBNP> 1000 pg / dL and the presence of at least two of the following congestion criteria will be required: Jugular pressuret> 10 cm, lower limb edema, ascites, or pleural effusion determined by chest x-ray or lung ultrasound.
• Necessity at the discretion of the doctor responsible for intravenous diuretic to relieve congestion.
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 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

- Hospital admission criteria in the opinion of the responsible physician.
- Systolic blood pressure <90 mmHg or> 180 mmHg.
- Heart rate> 150 bpm.
- Basal oxygen saturation less than 90%.
-Cardiogenic shock.
-Acute Pulmonary Edema.
- Clinically significant arrhythmia.
- Acute myocardial ischemia.
- Patients who are in a hemodialysis or peritoneal dialysis program.
- Patients with serum sodium below <125 mEq / L or> 145 mEq / L or serum potassium below 3.5 mEq / L.
- Hemoglobin less than 9 g / dL
- Acute coronary syndrome or cardiological procedure in the previous 4 weeks.
- Severe uncorrected valve disease except tricuspid regurgitation.
- Moderate or severe dementia, active delirium or psychiatric problems that make the intervention difficult.

- Patients in whom cardiac surgery or device implantation is planned in the following month
- Pregnancy or breastfeeding
- Inability to give informed consent in the absence of a legal officer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified