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NCT Number: NCT02643147

Loop Diuretic Dosage in Patients With Acute Heart Failure and Renal Failure: Conventional Versus Carbohydrate Antigen 125-guided Therapy (IMPROVE-HF)

Worsening renal function (WRF) is a frequent finding in patients with decompensated acute heart failure (AHF) and it is associated to increased length of hospitalization and higher morbidity and mortality. Traditionally, WRF in AHF setting has been attributed to low cardiac output, but recent evidence also suggests venous congestion play a crucial role. Loop diuretics are the mainstay treatment of AHF, but their use traditionally has been associated to WRF, but also renal function improvement in patients with unequivocal signs of congestion. Nevertheless, traditional symptoms or signs of patients with AHF have shown a limited accuracy to neither identify nor quantify the degree of venous congestion. Recent authors have reported that plasma levels of antigen carbohydrate 125 (CA125) are closely related to the degree of venous congestion.

The investigators hypothesize that CA125 may have a role for identifying the hyperhydrated (High CA125) patients that need high loop diuretic doses, and those with normal CA125 values needing low loop diuretic doses. In this randomized study (1:1) the investigators seek to evaluate whether a CA125 loop diuretic guided management therapy is superior to a standard strategy. The primary endpoint is the magnitude of changes of renal function at 24 and 72 hours after initiation of intravenous diuretic in an acute worsening of heart failure

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Key information

Conditions

Heart Failure Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with the diagnosis of acute heart failure (AHF) and the concurrence of the following conditions:

  • Presence of symptoms (dyspnea at rest or minimal exertion) and signs attributable to congestion (signs of congestion on chest radiography, or presence of peripheral edema or ascites, or jugular venous distension at 45 degrees or presence of crackles on auscultation).
  • Elevated natriuretic peptide (NT-proBNP> 1000 pg/ml or BNP> 100 mg/dl).
  • Creatinine ≥1,4 mg/dl on admission, provided that the estimated glomerular filtration rate less than 60 ml / min / m2.
  • Intent to be treated with loop diuretics intravenously.

Exclusion criteria

  • Life expectancy less than 6 months of life due to other comorbid conditions.
  • Cardiogenic shock.
  • Diagnosis of acute coronary syndrome in the previous 30 days.
  • Pregnancy at the time of inclusion.
  • Restrictive or Obstructive pulmonary disease or severe degree.
  • Chronic renal insufficiency in stage V (estimated glomerular filtration rate <15 ml / min / m2) or patient previously included in known dialysis program.
  • Participation in another clinical trial randomized at the time of inclusion.
  • Temperature ≥38 ° C or diagnosis of pneumonia.

Treatment and study plan

CA125 guided strategy

Drug

Initial dose of intravenous furosemide ≤80 mg / day regardless of prior dose of loop diuretics who were receiving.

Other names: Loop diuretic (Furosemide) dosage in CA125 ≤35 U/ml patients

Conventional strategy

Drug

The dosage of loop diuretics is done according to the presence of symptoms and signs of systemic congestion and current recommendations

Primary outcomes

  1. Change in renal function (GFR)

    Time frame: 24 and 72 hours

    Glomerular filtration rate (GFR) estimated by MDRD. Prespecified interim analysis of primary outcome will be made by protocol when first 100 patients are included.

Secondary outcomes

  1. Improvement in signs and symptoms of heart failure (NYHA)

    Time frame: 24 and 72 hours

    Evaluation of dyspnea (changes in the functional class of the New York Heart Association -NYHA)

  2. Improvement in signs and symptoms of heart failure (VAS)

    Time frame: 24 and 72 hours

    Evaluation of signs of systemic congestion, and patient global assessment (by visual analogue scale -VAS-)

  3. Changes in plasma levels of natriuretic peptide (NT-proBNP)

    Time frame: 72 hours

  4. Changes in plasma levels of high sensitive troponin

    Time frame: 72 hours

  5. Time required to change intravenous diuretics to oral administration.

    Time frame: Through study completion (30-day follow-up)

  6. Composite of all-cause mortality plus acute heart failure related rehospitalization

    Time frame: 30 days

    Number of events in each group during 30-day follow-up

  7. Change in renal function (creatinin)

    Time frame: 24 h, 72 h and 30 days

    Serum levels of creatinine

  8. Change in renal function (urea)

    Time frame: 24 h, 72 h and 30 days

    Serum levels of urea

  9. Change in renal function (cystatin C)

    Time frame: 24 h, 72 h and 30 days

    Serum levels of Cystatin C

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Acronym: IMPROVE-HF

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 31, 2015
Registry last updated
Feb 13, 2018

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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