Metabolic Alkalosis in Heart Failure

NCT04740242 | Completed

• 1 other identifier: ALCALOTIC
• Study Type: observational
• Target: 672
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure; Metabolic Alkalosis; Diuretics Drug Reactions; Decompensated Heart Failure; Acute Heart Failure

Keywords

metabolic alkasosis; heart failure

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  In-hospital mortality from all causes

  an average of 7 days

Secondary Outcomes (4)

• Mortality during follow-up

  Mortality at 30 and 90 days after hospital discharge

• Re-admission (all cause) during follow-up

  Re-admission at 30 and 90 days after hospital discharge

• Readmission for heart failure during follow-up

  Readmission for heart failure 30 and 90 days after hospital discharge

• Lenght of Hospital stay

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spanish Society of Internal Medicine: lead

Study Sites (1)

Internal Medicine Service, Hospital d'Olot (Girona)

Olot, Girona, 17800, Spain

Location

Related Publications (2)

• Galla JH. Metabolic alkalosis. J Am Soc Nephrol. 2000 Feb;11(2):369-375. doi: 10.1681/ASN.V112369. No abstract available.

  PMID: 10665945 BACKGROUND

• 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.

  PMID: 23481366 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Heart Failure Workin Group. Spanish Society of Internal Medicine

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 5, 2021
• Study Start: January 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: September 30, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)