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Trial record 1 of 1 for:    Spanish study hyperkalemia
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Spanish Study of Hyperkalaemia Incidence and Prognosis in Patients With Heart Failure and Reduced Ejection Fraction (SPANIK-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04141800
Recruitment Status : Completed
First Posted : October 28, 2019
Last Update Posted : May 25, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Maria G. Crespo Leiro, Spanish Society of Cardiology

Brief Summary:
  • Participant centres and researchers:

    20 National Public Health System hospitals. Cardiology specialist physicians

  • Clinical Research Ethics Committee (CREC):

Hospital 12 de Octubre, Madrid

- Main goal: To estimate prevalence and, in medium term basis (12 months), incidence of hyperkalaemia in heart failure (HF) outpatients with reduced ejection fraction (REF) and its relationship with non-optimal HF therapy and clinical outcomes (mortality and hospital admission).

- Study design: National multicentric prospective observational study that includes 12 months follow-up of consecutive cases of HF outpatients with REF. Inclusion baseline visit and follow -up visits at 12 months will be scheduled for collecting clinical and blood sample data of patients.

- Study population: The expected number of patients recruited in 20 Spanish research centres is 600.


Condition or disease
Heart Failure With Reduced Ejection Fraction Hyperkalemia

Show Show detailed description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 565 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Spanish Multicentric Study of Hyperkalaemia Prevalence, Incidence and Prognosis in Patients With Heart Failure and Reduced Ejection Fraction
Actual Study Start Date : April 30, 2019
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
Heart failure (HF) outpatients with reduced ejection fraction

Heart Failure (HF) with reduced ejection fraction (REF): Patients with confirmed diagnosis of HF and with ejection fraction<40%.

Hyperkalaemia: K+values> 5,4 mEq/L.

Optimal doses: the maximum doses of renin-angiotensin-aldosterone related drugs that, according to the physician's judgement, the patient can receive. If any of these drugs (ACIEs, ARB-II, MRAs or sacubitril-valsartan) is de novointroducedat the initial visit, optimal doses will be not considered established.

A previous personal history of diseases and/or outcomes will be registered according to the usual practice of every centre.




Primary Outcome Measures :
  1. One-year incidence of hyperkalemia [ Time Frame: 12 months ]
    New onset of serum K+ >5,4 mEq/L


Secondary Outcome Measures :
  1. Non-optimal heart failure therapy [ Time Frame: 12 months ]

    Proportion of patients using drugs with proven efficacy for HF with REF -but also linked with hyperkalaemia- (ACEIs/ARB-II/ARNI and MRAs)

    Proportion of patients with use of optimal doses (based on current ESC heart failure guidelines2) of the same drugs

    Proportion of patients that do not receive ACEi/ARB/ARNI (or at less than target dose) AND do not receive MRA either.

    Proportion of patients that receive ACEi/ARB/ARNI at target dose AND do not receive MRA.

    Proportion of patients that receive ACEi/ARB/ARNI at target dose AND receive MRA at less than target dose.

    Proportion of patients that receive ACEi/ARB/ARNI at target dose AND also receive MRA at target dose.


  2. One-year incidence of heart failure hospital admission [ Time Frame: 12 months ]
    One-year incidence of heart failure hospital admission

  3. One-year incidence of mortality [ Time Frame: 12 months ]
    Total mortality

  4. One-year incidence of heart failure hospital admission and/or mortality [ Time Frame: 12 months ]
    One-year incidence of heart failure hospital admission and/or mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The expected number of patients recruited in 20 Spanish research centres is 600.

The study population is composed of consecutive HF outpatients with REF from excellence Spanish centres.

The study will be performed in 20 Spanish centres, either SEC HF- excellence certified, integrating official research networks or with excellent performance proven in previous similar initiatives.

Every centre will include the first 30 consecutive cardiology outpatients who fulfil the inclusion criteria and that do not present any exclusion criteria. All pre-screened patients will be indicated, together with the reason of their exemption if occurs.

Criteria

Inclusion Criteria:

  1. Patients, women or men, aged 18 or more
  2. Documented HF with REF (<40%) diagnosis
  3. Signed written informed consent

Exclusion Criteria:

  1. Any type of disorder affecting the capacity to give free and informed written consent
  2. Clinical trial enrolment at the moment of the inclusion
  3. Patients suffering stage 5 chronic kidney disease
  4. Patients with less than a year life span due to diseases different from HF
  5. Not having completed HF drug titration stage at the moment of inclusion (this stage is not completed if, on doctor's judgement, possible maximum doses have not been reached in RAA system drugs and any of these drugs has been included or dose-modified in recruitment visit)
  6. Informed consent refusal

At any time during follow-up patients can leave the study (and will be censored in the analysis) or retire their consent (and will be excluded from the analysis).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141800


Locations
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Spain
Complejo Hospitalario Universitario de A Coruña (CHUAC)
A Coruña, Spain
Sponsors and Collaborators
Spanish Society of Cardiology
AstraZeneca
Investigators
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Principal Investigator: María G Crespo Leiro, MD, PhD Complejo Hospitalario Universitario de A Coruña (CHUAC)
Principal Investigator: Juan Delgado Jiménez, MD, PhD Hospital Universitario 12 de Octubre, Madrid
Principal Investigator: Javier Muñiz García, MD, PhD Instituto Universitario de Ciencias da Saúde. Universidade da Coruña. INIBIC
  Study Documents (Full-Text)

Documents provided by Maria G. Crespo Leiro, Spanish Society of Cardiology:
Study Protocol  [PDF] February 18, 2019

Publications:

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Responsible Party: Maria G. Crespo Leiro, Principal Investigator, Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT04141800    
Other Study ID Numbers: ESR-17-13244
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria G. Crespo Leiro, Spanish Society of Cardiology:
Hyperkalemia
Heart failure
Incidence
Ejection fraction
Additional relevant MeSH terms:
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Heart Failure
Hyperkalemia
Heart Diseases
Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases