Metabolic Alkalosis in Heart Failure

NCT ID: NCT04740242

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

672 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-09-30

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort of exposed patients (Group 1)

All patients admitted for decompensated HF and presenting MA at the time of admission

No interventions assigned to this group

Cohort of unexposed patients (Group 2)

All patients admitted for decompensated HF and who do NOT present MA at the time of admission

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Society of Internal Medicine

OTHER

Sponsor Role lead

Responsible Party

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Joan Carles Trullas Vila

Principal Investigator. Heart Failure Workin Group. Spanish Society of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Internal Medicine Service, Hospital d'Olot (Girona)

Olot, Girona, Spain

Site Status

Countries

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Spain

References

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

Reference Type BACKGROUND
PMID: 10665945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23481366 (View on PubMed)

Other Identifiers

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ALCALOTIC

Identifier Type: -

Identifier Source: org_study_id

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