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出境医 / 临床实验 / Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) in Patients With Symptomatic Heart Failure (THETIS)

Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) in Patients With Symptomatic Heart Failure (THETIS)

Study Description
Brief Summary:
Cardiac Heart Failure Questionnaire HF-Q) to assess the severity of the symptoms of Heart Failure. In this study, modified and translated, the "four-point" questionnaire by Severo and his associates - Heart Failure Questionnaire HF-Q, is used. The HF-Q Heart Failure Questionnaire consists of four closed questions: the first with four possible answers and the other three questions with the possibility of three simple-choice answers.

Condition or disease
Heart Failure Heart Failure NYHA Class III Heart Failure NYHA Class II Heart Failure NYHA Class IV

Detailed Description:

An important new element in recent guidelines is the recommendation to prevent the onset of heart failure syndrome and / or delay its progression. The degree of patient functional limitation is determined using the New York Heart Association (NYHA) classification, which in combination with the left ventricular ejection fraction is the main criterion for all clinical studies in HF.

Specifically, NYHA's functional classification is used to describe the severity of symptoms and exercise tolerance and includes 4 classes (I-IV) :

Class I: Unbound in physical activity. Conventional physical activity does not cause fatigue, palpitations or shortness of breath.

Class II: Mild limitation to physical activity. No symptoms in the calm, but ordinary physical activity causes fatigue, palpitations or shortness of breath.

Class III: Serious restriction to physical activity. No symptoms in the calm, but even mild physical activity causes fatigue, palpitations or shortness of breath.

Class IV: Inability to perform any physical activity without discomfort. Symptoms and seclusion. Strengthening the discomfort in any physical activity.

The study evaluates the predictive capacity of the Cardiac Deficiency Questionnaire (HF-Q) for the occurrence of Adverse Cardiovascular Stroke (MACE) according to the New York Heart Association (NYHA) Functional Classification of Heart Failure in patients with symptomatic Heart Failure .

This type of approach may be useful in the reproducibility of the results and the validity of the NYHA classification system, since the severity of the heart failure symptoms is recorded on the basis of the patient's own perception.

The term MACE or "Major Unwanted Cardiovascular Syndromes" is undoubtedly the most common and complex endpoint in cardiology research. Historically, the term MACE appears to be used in the mid-1990s with its use being mainly limited to the intra-muscular complications associated with transcutaneous coronary interventions (PCIs). Despite the widespread use of the term in clinical trials, the definitions of MACE may differ, which makes it difficult to compare similar studies.

The so-called "classic 3-point MACE" is defined based on the following17:

  • Cardiovascular Death
  • Myocardial infarction
  • Cerebral Episode (Ischemic or Haemorrhagic) In general, MACE terminology is a complex clinical event and includes endpoints that reflect both safety and efficacy.
Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: THETIS: Non-interventional, Multicenter Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) According to New York Heart Association Functional Classification (NYHA) in Patients With Symptomatic Heart Failure
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Heart Failure Questionnaire (HF-Q) [ Time Frame: 6 months ]
    HF-Q rating vs NYHA classification

  2. Major Adverse Cardiovascular Events (MACEs) [ Time Frame: 6 months ]
    Number of MACEs occured during the study


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with symptomatic Heart Failure NYHA≥2
Criteria

Inclusion Criteria:

  • Adult patients with symptomatic Heart Failure NYHA≥2
  • Patients who have fully understood the procedures of the study and have signed an informed consent form.

Exclusion Criteria:

  • Patients with asymptomatic heart failure (NYHA = 1)
  • Patients with severe motor impairment / mobility impairment (neurological diseases, muscular diseases, severe anemia, previous mobility stroke, severe malignancy, end-stage COPD)
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 13, 2019
Last Update Posted Date January 30, 2020
Estimated Study Start Date October 1, 2019
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2019)
  • Heart Failure Questionnaire (HF-Q) [ Time Frame: 6 months ]
    HF-Q rating vs NYHA classification
  • Major Adverse Cardiovascular Events (MACEs) [ Time Frame: 6 months ]
    Number of MACEs occured during the study
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) in Patients With Symptomatic Heart Failure
Official Title THETIS: Non-interventional, Multicenter Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) According to New York Heart Association Functional Classification (NYHA) in Patients With Symptomatic Heart Failure
Brief Summary Cardiac Heart Failure Questionnaire HF-Q) to assess the severity of the symptoms of Heart Failure. In this study, modified and translated, the "four-point" questionnaire by Severo and his associates - Heart Failure Questionnaire HF-Q, is used. The HF-Q Heart Failure Questionnaire consists of four closed questions: the first with four possible answers and the other three questions with the possibility of three simple-choice answers.
Detailed Description

An important new element in recent guidelines is the recommendation to prevent the onset of heart failure syndrome and / or delay its progression. The degree of patient functional limitation is determined using the New York Heart Association (NYHA) classification, which in combination with the left ventricular ejection fraction is the main criterion for all clinical studies in HF.

Specifically, NYHA's functional classification is used to describe the severity of symptoms and exercise tolerance and includes 4 classes (I-IV) :

Class I: Unbound in physical activity. Conventional physical activity does not cause fatigue, palpitations or shortness of breath.

Class II: Mild limitation to physical activity. No symptoms in the calm, but ordinary physical activity causes fatigue, palpitations or shortness of breath.

Class III: Serious restriction to physical activity. No symptoms in the calm, but even mild physical activity causes fatigue, palpitations or shortness of breath.

Class IV: Inability to perform any physical activity without discomfort. Symptoms and seclusion. Strengthening the discomfort in any physical activity.

The study evaluates the predictive capacity of the Cardiac Deficiency Questionnaire (HF-Q) for the occurrence of Adverse Cardiovascular Stroke (MACE) according to the New York Heart Association (NYHA) Functional Classification of Heart Failure in patients with symptomatic Heart Failure .

This type of approach may be useful in the reproducibility of the results and the validity of the NYHA classification system, since the severity of the heart failure symptoms is recorded on the basis of the patient's own perception.

The term MACE or "Major Unwanted Cardiovascular Syndromes" is undoubtedly the most common and complex endpoint in cardiology research. Historically, the term MACE appears to be used in the mid-1990s with its use being mainly limited to the intra-muscular complications associated with transcutaneous coronary interventions (PCIs). Despite the widespread use of the term in clinical trials, the definitions of MACE may differ, which makes it difficult to compare similar studies.

The so-called "classic 3-point MACE" is defined based on the following17:

  • Cardiovascular Death
  • Myocardial infarction
  • Cerebral Episode (Ischemic or Haemorrhagic) In general, MACE terminology is a complex clinical event and includes endpoints that reflect both safety and efficacy.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients with symptomatic Heart Failure NYHA≥2
Condition
  • Heart Failure
  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class IV
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart. 2007 Sep;93(9):1137-46. Review.
  • Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.
  • Mant J, Doust J, Roalfe A, Barton P, Cowie MR, Glasziou P, Mant D, McManus RJ, Holder R, Deeks J, Fletcher K, Qume M, Sohanpal S, Sanders S, Hobbs FD. Systematic review and individual patient data meta-analysis of diagnosis of heart failure, with modelling of implications of different diagnostic strategies in primary care. Health Technol Assess. 2009 Jul;13(32):1-207, iii. doi: 10.3310/hta13320. Review.
  • Mentz RJ, Cotter G, Cleland JG, Stevens SR, Chiswell K, Davison BA, Teerlink JR, Metra M, Voors AA, Grinfeld L, Ruda M, Mareev V, Lotan C, Bloomfield DM, Fiuzat M, Givertz MM, Ponikowski P, Massie BM, O'Connor CM. International differences in clinical characteristics, management, and outcomes in acute heart failure patients: better short-term outcomes in patients enrolled in Eastern Europe and Russia in the PROTECT trial. Eur J Heart Fail. 2014 Jun;16(6):614-24. doi: 10.1002/ejhf.92. Epub 2014 Apr 25.
  • Follath F, Yilmaz MB, Delgado JF, Parissis JT, Porcher R, Gayat E, Burrows N, McLean A, Vilas-Boas F, Mebazaa A. Clinical presentation, management and outcomes in the Acute Heart Failure Global Survey of Standard Treatment (ALARM-HF). Intensive Care Med. 2011 Apr;37(4):619-26. doi: 10.1007/s00134-010-2113-0. Epub 2011 Jan 6.
  • Clinical guideline Published: 8 October 2014 , nice.org.uk/guidance/cg187, Acute heart failure: diagnosis and management.
  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. Erratum in: Eur Heart J. 2016 Dec 30;:.
  • Tsioufis C, Iliakis P, Kasiakogias A, Konstantinidis D, Lovic D, Petras D, Doumas M, Tsiamis E, Papademetriou V, Tousoulis D. Non-pharmacological Modulation of the Autonomic Nervous System for Heart Failure Treatment: Where do We Stand? Curr Vasc Pharmacol. 2017;16(1):30-43. doi: 10.2174/1570161115666170428124756. Review.
  • NHFA CSANZ Heart Failure Guidelines Working Group, Atherton JJ, Sindone A, De Pasquale CG, Driscoll A, MacDonald PS, Hopper I, Kistler PM, Briffa T, Wong J, Abhayaratna W, Thomas L, Audehm R, Newton P, O'Loughlin J, Branagan M, Connell C. National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand: Guidelines for the Prevention, Detection, and Management of Heart Failure in Australia 2018. Heart Lung Circ. 2018 Oct;27(10):1123-1208. doi: 10.1016/j.hlc.2018.06.1042.
  • Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025. Epub 2017 Apr 28.
  • Raphael C, Briscoe C, Davies J, Ian Whinnett Z, Manisty C, Sutton R, Mayet J, Francis DP. Limitations of the New York Heart Association functional classification system and self-reported walking distances in chronic heart failure. Heart. 2007 Apr;93(4):476-82. Epub 2006 Sep 27.
  • Sandra L. Carroll et al., A Comparison of the NYHA Classification and the Duke Treadmill Score in Patients with Cardiovascular Disease, Open Journal of Nursing, 2014, 4, 774-783, SciRes. http://www.scirp.org/journal/ojn, http://dx.doi.org/10.4236/ojn.2014.411083.
  • Severo M, Gaio R, Lourenço P, Alvelos M, Bettencourt P, Azevedo A. Indirect calibration between clinical observers - application to the New York Heart Association functional classification system. BMC Res Notes. 2011 Aug 3;4:276. doi: 10.1186/1756-0500-4-276.
  • Kip KE, Hollabaugh K, Marroquin OC, Williams DO. The problem with composite end points in cardiovascular studies: the story of major adverse cardiac events and percutaneous coronary intervention. J Am Coll Cardiol. 2008 Feb 19;51(7):701-7. doi: 10.1016/j.jacc.2007.10.034. Review.
  • World Medical Association. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001;79(4):373-4. Epub 2003 Jul 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 28, 2020)
0
Original Estimated Enrollment
 (submitted: May 10, 2019)
3300
Estimated Study Completion Date January 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients with symptomatic Heart Failure NYHA≥2
  • Patients who have fully understood the procedures of the study and have signed an informed consent form.

Exclusion Criteria:

  • Patients with asymptomatic heart failure (NYHA = 1)
  • Patients with severe motor impairment / mobility impairment (neurological diseases, muscular diseases, severe anemia, previous mobility stroke, severe malignancy, end-stage COPD)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03947853
Other Study ID Numbers 2019-IVBR-EL-95
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Elpen Pharmaceutical Co. Inc.
Study Sponsor Elpen Pharmaceutical Co. Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Elpen Pharmaceutical Co. Inc.
Verification Date May 2019