Safety and Efficacy of the Combination of Loop With Thiazide-type Diureticsin Patients With Decompensated Heart Failure (CLOROTIC)

• Conditions: Security and efficacy of Hidroclorothiazide plus Loop Diuretics in patients with descompensated heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001852-36-ES
• Lead Sponsor: Sociedad Española de Medicina Interna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-12
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients eligible for inclusion in this study must meet all the following criteria:
Male or female patients aged less than 18 years old.
Patients with chronic HF prior (from any cause and regardless of the degree of ventricular dysfunction) according to the criteria of the European Society of Cardiology [15] admitted for decompensation defined as presence of at least one symptom (dyspnea, orthopnea or edema) and a sign (rales on auscultation, third heart sound, peripheral edema, ascites, pulmonary vascular congestion on chest radiograph)
Patients should be taking loop diuretic orally chronically (at least one month).
Previous doses of oral diuretics should be: between 80 and 160 oral furosemide and equivalent doses for other loop diuretics (torasemide 20mg and 1 mg of bumetanide are considered equivalent to 40 mg of furosemide).
Patients must give their written informed consent to participate in the study and before they do any of the study-related evaluations.
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 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 354

Exclusion Criteria

Patients who have any of the following criteria may not participate in the study:
BNP plasma levels of <100 pg / ml, or NT-pBNP <300 pg / ml
Patients previously diagnosed with severe aortic stenosis
Patients with decompensated edematous etiology other than the CI right HF secondary to pulmonary hypertension and / or pulmonary embolism, liver cirrhosis, nephrotic syndrome, etc..
Patients with hyponatremia at the time of selection: be excluded any value of Hippo + that is symptomatic or when sodium (Na +) levels less than or equal to 125mEq / L.
Patients with acute coronary syndrome at the time of admission.
Patients in cardiogenic xoc situation at the time of admission.
Patients requiring admission to the Intensive Care Unit / Coronary Care Unit
Patients requiring treatment with vasoactive drugs (dopamine, dobutamine, norepinephrine) at admission. It allows patients to receive treatment with vasoactive drugs on admission (at the discretion of the attending physician) and it will not be a reason by itself sufficient for removal of the patient from the study.
Patients requiring renal replacement therapy: hemodialysis, hemodiafiltration, ultrafiltration, etc..
Patients with a life expectancy less than 6 months at the time the income is not attributable to heart failure
Patients treated with HCTZ or other thiazide diuretic during the month prior to admission.
Patients treated with aldosterone antagonists initiated within 30 days of entry. Allowing the patient is taking aldosterone if taken stably for more than one month.
Pregnant or breastfeeding.
History or evidence of drug or alcohol abuse in the last 12 months.
Any surgical or medical condition which in the opinion of the investigator, may put the patient at a higher risk because of their participation in the study, or is likely to prevent the patient meets the requirements of the study or the end of the study.
History of noncompliance with medical regimens or who is not willing meet the study protocol.
Any condition that, in the opinion of the investigator, could jeopardize the evaluation of the efficacy or safety.
Lack of acceptance by the patient to participate in the study.
Having participated in other clinical trials during the previous 3 months

Study & Design

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