Metabolic Alkalosis in Heart Failure

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Decompensated Heart Failure; Acute Heart Failure; Diuretics Drug Reactions; Metabolic Alkalosis

• Study Type: Observational
• Enrollment (Actual): 672

Contacts and Locations

Study Locations

• Spain
  • Girona
    • Olot, Girona, Spain, 17800
      • Internal Medicine Service, Hospital d'Olot (Girona)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients will be recruited from the Internal Medicine Services of Spanish Hospitals whose researchers are active members of the Working Group on Heart Failure and Atrial Fibrillation of the Spanish Society of Internal Medicine

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort of exposed patients (Group 1); All patients admitted for decompensated HF and presenting MA at the time of admission
Cohort of unexposed patients (Group 2); All patients admitted for decompensated HF and who do NOT present MA at the time of admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	In-hospital mortality from all causes	an average of 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality during follow-up	All-cause mortality 30 and 90 days after hospital discharge	Mortality at 30 and 90 days after hospital discharge
Re-admission (all cause) during follow-up	Re-admission for all causes 30 and 90 days after hospital discharge	Re-admission at 30 and 90 days after hospital discharge
Readmission for heart failure during follow-up	Re-admission for heart failure 30 and 90 days after hospital discharge	Readmission for heart failure 30 and 90 days after hospital discharge
Lenght of Hospital stay	Lenght of Hospital stay during hospital admission	Lenght of Hospital stay will be determined the day of hospital discharge, an average of 7 days after admission/inclusion

Collaborators and Investigators

• Sponsor: Spanish Society of Internal Medicine

Publications and helpful links

General Publications

• Galla JH. Metabolic alkalosis. J Am Soc Nephrol. 2000 Feb;11(2):369-375. doi: 10.1681/ASN.V112369. No abstract available.
• Peixoto AJ, Alpern RJ. Treatment of severe metabolic alkalosis in a patient with congestive heart failure. Am J Kidney Dis. 2013 May;61(5):822-7. doi: 10.1053/j.ajkd.2012.10.028. Epub 2013 Mar 5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: January 30, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (ACTUAL): February 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: heart failure; metabolic alkasosis
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Acid-Base Imbalance; Heart Failure; Drug-Related Side Effects and Adverse Reactions; Alkalosis
• Other Study ID Numbers: ALCALOTIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No