Heart FailureNCT04740242
Metabolic Alkalosis in Heart Failure
An observational study of Heart Failure and Metabolic Alkalosis, run by Spanish Society of Internal Medicine at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Metabolic Alkalosis, Diuretics Drug Reactions
- How many people
- 672 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Internal Medicine Service, Hospital d'Olot (Girona)
Olot, Girona, 17800
About this study
Official title: 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.
Read more
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:
- To determine the prevalence of MA in patients admitted for decompensated HF
- To analyze if there are differences in patients admitted for HF according to the presence of MA on admission
- 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
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
In-hospital mortality from all causes
Measured: an average of 7 days
Secondary outcomes (4)
Mortality during follow-up
All-cause mortality 30 and 90 days after hospital discharge
Measured: 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
Measured: 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
Measured: Readmission for heart failure 30 and 90 days after hospital discharge
Lenght of Hospital stay
Lenght of Hospital stay during hospital admission
Measured: Lenght of Hospital stay will be determined the day of hospital discharge, an average of 7 days after admission/inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Jan 2021
- Primary completion31 May 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 672 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Internal Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Carles Trullas Vila, Spanish Society of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740242
- Sponsor's protocol ID
- ALCALOTIC
- Status last verified
- May 2022
- First submitted
- 30 Jan 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galla JH. Metabolic alkalosis. J Am Soc Nephrol. 2000 Feb;11(2):369-375. doi: 10.1681/ASN.V112369. No abstract available.
PubMed 10665945Peixoto 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.
PubMed 23481366Nunez J, Minana G, Villalonga M, Asenjo M, Carrera M, Epelde F, Gil M, Chivite D, Contra A, Pla X, Casado J, Miro O, de la Espriella R, Testani JM, Trullas JC; ALCALOTIC study investigators. Serum chloride and the response to combining loop and thiazide diuretics for acute heart failure: the ALCALOTIC study. Intern Emerg Med. 2025 Aug;20(5):1399-1409. doi: 10.1007/s11739-025-03961-z. Epub 2025 May 17.
PubMed 40379935
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALCALOTIC Study: Metabolic Alcalosis in Decompensated Heart Failure: Prevalence and Influence on Prognosis
- ClinicalTrials.gov ID
- NCT04740242
- Acronym / sponsor ID
- ALCALOTIC
- Conditions
- Heart Failure, Metabolic Alkalosis, Diuretics Drug Reactions, Decompensated Heart Failure, Acute Heart Failure
- Keywords
- metabolic alkasosis, heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- Spanish Society of Internal MedicineUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the prevalence of MA in patients admitted for decompensated HF
- To analyze if there are differences in patients admitted for HF according to the presence of MA on admission
- To determine if the presence of MA has an influence on the short-term prognosis in patients admitted for decompensated HF
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: an average of 7 days
In-hospital mortality from all causes
4 secondary outcomes
Mortality during follow-up
Time frame: Mortality at 30 and 90 days after hospital discharge
Re-admission (all cause) during follow-up
Time frame: Re-admission at 30 and 90 days after hospital discharge
Readmission for heart failure during follow-up
Time frame: Readmission for heart failure 30 and 90 days after hospital discharge
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Background: PubMed 10665945Galla JH. Metabolic alkalosis. J Am Soc Nephrol. 2000 Feb;11(2):369-375. doi: 10.1681/ASN.V112369. No abstract available.
- Background: PubMed 23481366Peixoto 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.
- Derived from this study: PubMed 40379935Nunez J, Minana G, Villalonga M, Asenjo M, Carrera M, Epelde F, Gil M, Chivite D, Contra A, Pla X, Casado J, Miro O, de la Espriella R, Testani JM, Trullas JC; ALCALOTIC study investigators. Serum chloride and the response to combining loop and thiazide diuretics for acute heart failure: the ALCALOTIC study. Intern Emerg Med. 2025 Aug;20(5):1399-1409. doi: 10.1007/s11739-025-03961-z. Epub 2025 May 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Metabolic Alkalosis, run by Spanish Society of Internal Medicine at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04740242, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.