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NCT Number: NCT04740242

Metabolic Alkalosis in Heart Failure

Metabolic alkalosis (MA) is the most common acid-base disorder and when it's severe it can have effects on cellular function and contribute to an increase in mortality.

MA is a common complication of heart failure (HF) especially when patients are treated with diuretics, but few studies have analyzed the prevalence of acid-base disorders in patients with HF.

All these studies have shown that MA is more common in patients with HF in more advanced stages and that the use of diuretics increases the prevalence of MA.

The study hypothesis, based on clinical experience and the few data that exist in the scientific literature, is that MA is a frequent analytical disorder in patients admitted for decompensated HF and that its presence entails a worse short-term vital prognosis.

The ALCALOTIC study is an observational cohort and prospective study.

The main objectives of the study are the following:

1. To determine the prevalence of MA in patients admitted for decompensated HF 2. To analyze if there are differences in patients admitted for HF according to the presence of MA on admission 3. To determine if the presence of MA has an influence on the short-term prognosis in patients admitted for decompensated HF

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Key information

Conditions

Heart Failure Acute Heart Failure Cardiovascular Diseases Decompensated Heart Failure Diuretics Drug Reactions Heart Diseases Metabolic Alkalosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Internal Medicine Service, Hospital d'Olot (Girona)

Olot, Girona, 17800, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient admitted for decompensated HF (main admission diagnosis), who meet the diagnostic criteria of the 2016 European HF Guidelines and who sign the informed consent to participate in the study
  • Patients must give their written consent to participate in the study

Exclusion criteria

  • Patients whose main reason for admission is not decompensated HF. Those patients who are admitted for another reason and who also have decompensated HF secondarily cannot be included
  • Patients who do not strictly meet the diagnostic criteria for HF of the European HF Guidelines.
  • Patients for whom analytical values are not available in relation to acid-base balance at the time of admission
  • Patients with a pathological history that can clearly justify metabolic alkalosis, such as primary or secondary hyperaldosterism
  • Patients who were taking sodium bicarbonate prior to admission
  • Patients with factors present at admission that may justify the presence of metabolis alkalosis: vomiting, diarrea, etc.
  • Patients who do not give their consent to participate in the study

Treatment and study plan

Primary outcomes

  1. In-hospital mortality

    Time frame: an average of 7 days

    In-hospital mortality from all causes

Secondary outcomes

  1. Mortality during follow-up

    Time frame: Mortality at 30 and 90 days after hospital discharge

    All-cause mortality 30 and 90 days after hospital discharge

  2. Re-admission (all cause) during follow-up

    Time frame: Re-admission at 30 and 90 days after hospital discharge

    Re-admission for all causes 30 and 90 days after hospital discharge

  3. Readmission for heart failure during follow-up

    Time frame: Readmission for heart failure 30 and 90 days after hospital discharge

    Re-admission for heart failure 30 and 90 days after hospital discharge

  4. Lenght of Hospital stay

    Time frame: Lenght of Hospital stay will be determined the day of hospital discharge, an average of 7 days after admission/inclusion

    Lenght of Hospital stay during hospital admission

Sponsors and collaborators

Lead sponsor

Spanish Society of Internal Medicine

Other

Registry information

Official study title

ALCALOTIC Study: Metabolic Alcalosis in Decompensated Heart Failure: Prevalence and Influence on Prognosis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
May 4, 2022

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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