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Prevalence of Amyloidosis in Heart Failure (PREVAMIC) (PREVAMIC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066452
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:

TITLE: Study of Prevalence of Amyloidosis in Heart Failure: PREVAMIC.

DESIGN: Multicenter, observational, cross-sectional, prospective, cohort study with a one-year follow-up. 44 hospitals from Spain will participate.

OBJECTIVES. PRIMARY: To estimate the current prevalence of different types of cardiac amyloidosis (CA) in patients with heart failure, aged 65 years and older, with LVH > 12 mm and any LVEF value, managed in Internal Medicine departments. SECONDARY: To describe the clinical, laboratory and echocardiographic features of patients with CA. To compare one-year readmissions and mortality rates in patients with and without CA.

INCLUSION CRITERIA: Inpatients or outpatients with heart failure, aged ≥ 65 years, both genders, under the care of internists. They should have a NYHA Class II-IV, echocardiogram performed in the previous 24 months, any value of LVEF, LVH: septum or posterior wall > 12 mm, diuretic treatment in the last 6 months and NTproBNP> 1800 pg/ml or BNP> 400 pg/ml in acute hear failure, or NT-proBNP >600 pg/ml o BNP >150 pg/ml in stable condition.

POPULATION: Heart failure outpatients or inpatients of Internal Medicine Services. It is expected to include around 450 patients.

ANALYSIS: To calculate the prevalence of TTR-CA and other types of CA. To compare the clinical, analytical, echocardiographic, and readmissions and mortality rates during one-year in patients with and without CA.


Condition or disease Intervention/treatment
Heart Failure Diagnostic Test: Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP). Diagnostic Test: Proteinogram and serum immunoglobulins. Light chains free in serum -Freelite-. Immunofixation in serum and urine

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Prevalence of Amyloidosis in Heart Failure (PREVAMIC).
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Single-group studies

Patients will be informed about the study and their written informed consent will be requested.

Once included in the study:

  • A series of clinical, analytical and echocardiographic parameters will be collected and measured
  • Will be performed:

    • Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP)
    • Analytical to rule out monoclonal protein:

      • Proteinogram and serum immunoglobulins.
      • Light chains free in serum -Freelite-
      • Immunofixation in serum and urine.
  • The number of readmissions, emergency visits and mortality in the following 12 months will be recorded to compare the readmission and mortality rates in one year of patients with and without CA.
  • The prescribed pre- and post-diagnostic treatments will be described, according to clinical practice (without intervention).
  • No intervention, whether diagnostic or follow-up, that is not the usual clinical practice will be applied to patients.
Diagnostic Test: Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP).
Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP) to evaluate the degree of cardiac uptake from 0 to 3 degrees.

Diagnostic Test: Proteinogram and serum immunoglobulins. Light chains free in serum -Freelite-. Immunofixation in serum and urine
Analysis to rule out the presence of monoclonal protein in blood and urine.




Primary Outcome Measures :
  1. Prevalence [ Time Frame: Through study completion, an average of one year. ]
    To estimate the current prevalence of different types of Cardiac Amyloidosis in patients with Heart Failure, age ≥ 65 years, with left ventricular hypertrophy (LVH)> 12 mm, and any LVEF value, under the care of internists in different Spanish Hospitals.


Secondary Outcome Measures :
  1. Patients characteristics [ Time Frame: One year ]
    To describe the clinical, laboratory and echocardiographic features of patients with CA.

  2. Prognosis [ Time Frame: One year ]
    To compare one-year readmissions and mortality rates in patients with and without AC.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
- Heart failure outpatients or inpatients of Internal Medicine Services of 44 hospitals from Spain. Age ≥ 65 years. Both genders.
Criteria

Inclusion Criteria:

  • Age ≥ 65 years.
  • Both genders
  • Heart failure outpatients or inpatients of Internal Medicine Services.
  • Heart Failure (Criteria of HF European Guide 2016)
  • Symptoms of HF
  • NYHA class II to IV
  • Echocardiogram performed in the previous 24 months
  • FEVI: any value
  • HVI: Septum or Posterior Wall > 12 mm
  • Diuretic treatment in the last 6 months
  • NTproBNP > 1800 or BNP > 400 during any hospital admission, or NTproBNP > 600 or BNP > 150 in a stable situation.

Exclusion Criteria:

  • Patients with cancer disease (solid tumor)
  • Patients who are included in other studies or clinical trial
  • Refusal of patients 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): NCT04066452


Contacts
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Contact: Oscar Aramburu Bodas Aramburu Bodas oscarab2000@gmail.com
Contact: Oscar Aramburu Bodas 955 00 80 00 oscarab2000@gmail.com

Locations
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Spain
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41071
Contact: Oscar Aramburu-Bodas, PhD, MD    654038491    OSCARAB2000@GMAIL.COM   
Contact: Prado Salamanca-Bautista, PhD, MD    +34 605344922    PRADOSALAMANCA@GMAIL.COM   
Sub-Investigator: ROCÍO RUIZ-HUESO         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Principal Investigator: Prado Salamanca Bautista Hospital Universitario Virgen Macarena
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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT04066452    
Other Study ID Numbers: FIS-AMI-2019-01
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: August 2019

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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 Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Amyloidosis
Additional relevant MeSH terms:
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Heart Failure
Amyloidosis
Heart Diseases
Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs