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A Survey to Assess Effects of Covid-19 on Cardiovascular Patients

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ClinicalTrials.gov Identifier: NCT04508920
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborators:
Instituto Nacional de Cardiologia Ignacio Chavez
Medica Sur Clinic & Foundation
Information provided by (Responsible Party):
EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC, Centro en Insuficiencia Cardiaca, Mexico

Brief Summary:
The design included 152 patients with confirmed heart failure (HF) evaluated in two different periods of time: a baseline before the outbreak, and other during the outbreak of which 76 patients were randomized in each group. A care and follow-up guide was used as an instrument through a face-to-face survey (baseline group) and telemedicine (group outbreak). The primary outcome was the comparison of functional class modification observed in patients

Condition or disease Intervention/treatment
Cardiovascular Diseases Heart Failure Other: Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA)

Detailed Description:

Population and Data Sources All patients included, confirmed diagnosis of HF, according with the ESC guidelines criteria, both genders, above 18 years, who agreed to participate. All HF outpatients belonged to an open follow-up cohort of the HF clinic of the National Institute of Cardiology of Mexico, which started enrollment since September 2016. Periodic determinations were planned, clinical, functional, therapeutic evaluations, and emotional distress. The present design is a nested comparative analysis through a care and follow-up guide to HF patients.

Data collection and outcomes Interventions were recorded in two groups of patients, who were randomly selected, in two different periods of time. The basal group was intervened from 15 May to 15 June 2019, a pandemic-free period. The outbreak group from 15 May to 15 June 2020, corresponding to increased activity of contagiousness and mortality associated with COVID-19, in general population in Mexico.

Basal measurement was performed in a face to face method. In Outbreak period, under social isolation conditions, patients were evaluated by telephone. The assessments were performed out by medical staff with specialized training, with evaluations to which patients were accustomed by regular cohort assessments. The questions were ordered and systematized in a patient evaluation, care, and follow-up guide . A causality association question of emotional distress perception was added. Investigators recorded mortality and rehospitalization.

The primary outcome was comparison of functional class modification, secondary outcomes were Clinical alterations related to HF worsening, Therapeutic modifications, Daily physical activities, and Self-perception of health status.

The protocol conducted to hypothesize that the clinical alarm data reported by patients, in an alternative in-home model, with tele-medical assistance, is a useful tool in follow-up, as in detecting therapeutic performances, and associated with the HF deterioration.

Protocol was approved by the ethics and investigational committees. All patients previously signed informed consent. Additionally, prior to the telephone survey, a verbal assent was requested. Absolute confidentiality of all patient data was declared.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: A Survey to Assess Effects of the Covid-19 Pandemic on Symptomatology, Treatment and Medical Care for Cardiovascular Patients
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : July 15, 2021

Group/Cohort Intervention/treatment
Basal

All adults (age >18 years), both gender, Heart failure patients (european society of cardiology ) criteria, sign consent.

A survey to access information about symptomatology, treatment, and medical care in period may 15 to june 15, 2019 ( without covid-19 )

Other: Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA)
Interventions were recorded in two groups of patients, who were randomly selected, in two different periods of time. The basal group was intervened from 15 May to 15 June 2019, a pandemic-free period. The outbreak group from 15 May to 15 June 2020, corresponding to increased activity of contagiousness and mortality associated with COVID-19, in general population in Mexico14 Basal measurement was performed in a face to face method. In Outbreak period, under social isolation conditions, patients were evaluated by telephone. The assessments were performed out by medical staff with specialized training, with evaluations to which patients were accustomed by regular cohort assessments. The questions were ordered and systematized in a patient evaluation, care, and follow-up guide (appendix). A causality association question of emotional distress perception was added. We recorded mortality and rehospitalization
Other Name: STRATA survey

Ourbreak

All adults (age >18 years), both gender, Heart failure patients (european society of cardiology ) criteria, sign consent.

A survey to access information about symptomatology, treatment, and medical care in period may 15 to june 15, 2020 ( ongoing covid-19 )

Other: Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA)
Interventions were recorded in two groups of patients, who were randomly selected, in two different periods of time. The basal group was intervened from 15 May to 15 June 2019, a pandemic-free period. The outbreak group from 15 May to 15 June 2020, corresponding to increased activity of contagiousness and mortality associated with COVID-19, in general population in Mexico14 Basal measurement was performed in a face to face method. In Outbreak period, under social isolation conditions, patients were evaluated by telephone. The assessments were performed out by medical staff with specialized training, with evaluations to which patients were accustomed by regular cohort assessments. The questions were ordered and systematized in a patient evaluation, care, and follow-up guide (appendix). A causality association question of emotional distress perception was added. We recorded mortality and rehospitalization
Other Name: STRATA survey




Primary Outcome Measures :
  1. NYHA class deterioration [ Time Frame: 1 year ]
    NYHA class modification in the last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). NYHA Scale: Minimum: 1 to maximum :4


Secondary Outcome Measures :
  1. Dyspnea deterioration [ Time Frame: 1 year ]
    physiological parameter to worsening of shortness of breath perception, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021).Dichotomic scale presence or absence

  2. Paroxysmal nocturnal dyspnea deterioration [ Time Frame: 1 year ]
    Physiological parameter to worsening of dyspnea that suddenly occurs to decubitus, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). Dichotomic scale presence or absence.

  3. Edema [ Time Frame: 1 year ]
    Physiological parameter to worsening of quantification of swollen ankles in both pelvic limbs, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). Dichotomic scale presence or absence

  4. Daily activities In the last four weeks? Please, mention if you a perceived limitation on : Walking deterioration [ Time Frame: 1 year ]
    a perceived limitation on walking more 500 meters, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). Dichotomic scale presence or absence.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All HF outpatients belonged to an open follow-up cohort of the HF clinic of the National Institute of Cardiology of Mexico, which started enrollment since September 2016.
Criteria

Inclusion Criteria:

  • confirmed diagnosis of HF, according with the ESC guidelines criteria
  • both genders,
  • above 18 years,
  • agreed to participate

Exclusion Criteria:

  • Impediment to contacting patients
  • marked physical impairment
  • cognitive impairment that prevents optimal interrogation
  • Cultural barriers involving communication limitation (languages, dialects, reading and writing)
  • Patient doesn't want to participate.

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): NCT04508920


Contacts
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Contact: EDUARDO CHUQUIURE-VALENZUELA, MD +525554017407 echuquiurev@yahoo.com
Contact: ALAN FUENTES-MENDOZA, MD +524621073512 alan_fm@hotmail.com

Locations
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Mexico
Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia Recruiting
Mexico City, Mexico, 14080
Contact: CHUQUIURE-VALENZUELA EDUARDO, MD, MSc    +5215554017407    echuquiurev@yahoo.com   
Principal Investigator: EDUARDO CHUQUIURE-VALENZUELA, MD MSc         
Sub-Investigator: ALAN FUENTES, MD         
Sponsors and Collaborators
Centro en Insuficiencia Cardiaca, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Medica Sur Clinic & Foundation
Investigators
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Principal Investigator: EDUARDO CHUQUIURE-VALENZUELA, MD Centro en insuficiencia cardiaca
  Study Documents (Full-Text)

Documents provided by EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC, Centro en Insuficiencia Cardiaca, Mexico:
Publications of Results:
Other Publications:

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Responsible Party: EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC, Principal investigator, Centro en Insuficiencia Cardiaca, Mexico
ClinicalTrials.gov Identifier: NCT04508920    
Other Study ID Numbers: 20-1156
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

IPD PLAN Eduardo Chuquiure-Valenzuela is Principal investigator, conceptual protocol designer, performed statistics, write manuscript and draft corrections.

Alan Fuentes-Mendoza, Emmanuel Tapia-López, Daniel García-Romero Elyz Cortez-Lopez and Alejandra Marin-Sanchez, collaborate in clinical, research and analysis activities for CENTRO EN INSUFICIENCIA CARDIACA, Also, they assist in telephone interviews, writing of the manuscript. performed and checked statistics, co- writer, and draft corrections.

Laura Rodríguez Chávez, Nilda Espíndola Zavaleta, Gerardo Vieyra Herrera, and Enrique Lopez Mora, are affiliated cardiologists, who participate in the draft revision for publication.

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: august 1, 2021 to december 30,2021
Access Criteria: open access
URL: http://cardiologia.org.mx

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases