Metabolic Alkalosis in Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740242
• Other study ID #: ALCALOTIC
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2022
• Source: Spanish Society of Internal Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 672
• Est. completion date: September 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Alkalosis
• Decompensated Heart Failure
• Diuretics Drug Reactions
• Drug-Related Side Effects and Adverse Reactions
• Heart Failure
• Metabolic Alkalosis

Locations

Country	Name	City	State
Spain	Internal Medicine Service, Hospital d'Olot (Girona)	Olot	Girona

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Internal Medicine

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Galla JH. Metabolic alkalosis. J Am Soc Nephrol. 2000 Feb;11(2):369-375. doi: 10.1681/ASN.V112369. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality	In-hospital mortality from all causes	an average of 7 days
Secondary	Mortality during follow-up	All-cause mortality 30 and 90 days after hospital discharge	Mortality at 30 and 90 days after hospital discharge
Secondary	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
Secondary	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
Secondary	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