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Effect of one or two diuretics in patients with decompensated heart failure - a clinical trial

Effect of diuretic combination in patients with acutely decompensated heart failure - a randomized clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-5qkn8h
Enrollment
Unknown
Registered
2019-07-23
Start date
2015-09-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Intervention group: 32 patients will be given one capsule of hydrochlorothiazide 50 mg once daily (preferably in the morning), minimum 1 day, maximum 3 days (maximum duration of intervention). Adminis
Drug

Sponsors

Hospital de Clínicas de Porto Alegre
Lead Sponsor
Hospital de Clínicas de Porto Alegre
Collaborator

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of acutely decompensated heart failure; age greater than 18 years; male and female; emergency admission for less than 18 hours; signs of congestion (lower limb edema, pulmonary crackles, chest X-ray with signs of congestion, jugular swelling or hepatojugular reflux, weight gain greater than 4.5 kg); endogenous creatinine clearance greater than 30 ml / min; serum potassium between 3.5 and 5.1 mEq / L; ejection fraction equal to or less than 45% in the last 12 months; to sign a free and informed consent form.

Exclusion criteria

Exclusion criteria: Hypernatremia; Bartter or Gitelman syndrome; renal tubular acidosis type IV; allergy to sulfa; validity of acute coronary syndrome; history of gout; gestation or lactation; septic shock; hepatic dysfunction (elevation of transaminases three times the reference value); inability to enteral intake.

Design outcomes

Primary

MeasureTime frame
Congestion reduction (weight loss of 1.8 kg) is expected to be achieved, with daily weighing machine, during administration of the medication or placebo, according to randomization), by comparing weight before intervention and after the end of it.

Secondary

MeasureTime frame
A loss of 1.8 kg or a reduction of 30% of the NT-proBNP will be evaluated through a laboratory kit, before and after the intervention, in 3 days.;We will evaluate variation of BNP in 3 days (or discharge, if before) and at the end of hospitalization, through a laboratory kit, compared to values before the start of the intervention.;A 3-day creatinine variation (or discharge, if earlier) will be evaluated and at the end of hospitalization, using a laboratory kit, compared to values before the start of the intervention.;The need to use vasoactive drugs (sodium nitroprusside, nitroglycerin, dobutamine, milrinone) will be assessed over the study intervention days.;The congestion score (composed of 6 variables, each with a value of 1 point, being jugular, hepatojugular reflux, peripheral edema, crackling, third bulge, orthopnea) between the groups, before and after the intervention, will be evaluated.;The dyspnea score (Likert scale and area on the curve between Likert scale and time) will be evaluated between the groups, before the intervention and after.;The weight variation will be evaluated before after the intervention between the groups, through a weighting machine;The hospitalization time between the control and intervention groups will be evaluated.;Variation of hematimetric parameters (hematocrit and hemoglobin, by laboratory measurement) will be evaluated, before and after 3 days of intervention.;Hepatic function (TGO, TGP, bilirubin, alkaline phosphatase, gamma-GT, by laboratory measurement) will be assessed before and after intervention in both groups.;Re-hospitalization for decompensated heart failure (defined by the inclusion criteria of the present study) will be evaluated in 30 days (through telephone contact and / or patient chart review) in both groups.;Subjective site scale will be evaluated (value from 0 (no thirst) to 10 (intense thirst), in area on the curve - thirst x time) in both groups, before and after the intervention.;It will be assessed mort

Countries

Brazil

Contacts

Public ContactDiogo Piardi

Hospital de Clínicas de Porto Alegre

dpiardi@gmail.com+5551992574707

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 21, 2026