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OpenTrials
Completed

NCT Number: NCT01857999

Losartan in Decompensated Heart Failure

The dual blockade of the renin-angiotensin-aldosterone system with an angiotensin-converting enzyme inhibitor and an angiotensin-receptor blocker used together in heart failure patients has been demonstrated to be beneficial. However, the dual inhibition has not been studied during heart failure decompensation or even when low cardiac output is present.

The objective of this study was to assess the effects of add-on therapy with angiotensin receptor blocker on plasma B-type natriuretic peptide levels and hemodynamic measurements in heart failure patients with low cardiac output during hospitalization for decompensation.

This was a randomized, double-blind, placebo-controlled clinical trial.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cotoxó Hospital, Heart Institute (InCor), University of São Paulo

São Paulo, 05021-010, Brazil

About this study

The inclusion criteria were hospitalization for decompensated heart failure defined by worsening of symptoms until fatigue or dyspnea at rest, low cardiac output defined by the clinical-hemodynamic profile, dobutamine dependence, and ejection fraction < 0.45, spontaneous breathing and receiving angiotensin-converting enzyme inhibitors. The patients could have jugular ingurgitation, lower limbs edema, ascites and rales. Dobutamine dependence was defined by infusion for more than 15 days or an unsuccessful attempt of withdrawal.

The exclusion criteria were serum creatinine > 3.0 mg/dL, serum potassium > 6.0 mEq/L, systolic blood pressure < 70 mm Hg, aortic stenosis, and acute coronary syndrome in the previous 2 months. The patients were randomly assigned by permuted block of 4, stratified by sex, to losartan or placebo.

The endpoints were change in B-type natriuretic peptide levels, cardiac index, pulmonary wedge capillary pressure, systemic vascular resistance, and successful withdrawal of dobutamine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hospitalization for decompensated heart failure
  • dobutamine dependence
  • ejection fraction < 0.45
  • taking angiotensin-converting enzyme inhibitor

Exclusion criteria

  • serum creatinine > 3.0 mg/dL
  • serum potassium > 6.0 mEq/L
  • systolic blood pressure < 70 mm Hg
  • aortic stenosis
  • acute coronary syndrome in the previous 2 months

Treatment and study plan

Losartan

Drug

Placebo

Drug

Primary outcomes

  1. B-type natriuretic peptide

    Time frame: 7 days

    Serum B-type natriuretic peptide

Secondary outcomes

  1. Successful withdrawal from dobutamine

    Time frame: 7 days

    Successful withdrawal from dobutamine with clinical stability

  2. Worsening renal function

    Time frame: 7 days

    Increase > 0.3 mg/dL in serum creatinine

  3. Hyperkalemia

    Time frame: 7 days

    Serum potassium > 5.5 mEq/L

  4. Hypotension

    Time frame: 7 days

    Systolic blood pressure < 80 mmHg

Sponsors and collaborators

Lead sponsor

InCor Heart Institute

Other

Registry information

Official study title

Short-term add-on Therapy With Angiotensin Receptor Blocker for End-stage Inotrope-dependent Heart Failure Patients: B-type Natriuretic Peptide Reduction in a Randomized Clinical Trial

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 20, 2013
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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