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

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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

Tracking Information
First Submitted Date August 20, 2019
First Posted Date August 26, 2019
Last Update Posted Date March 5, 2020
Actual Study Start Date February 3, 2020
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 22, 2019)
  • Patients characteristics [ Time Frame: One year ]
    To describe the clinical, laboratory and echocardiographic features of patients with CA.
  • Prognosis [ Time Frame: One year ]
    To compare one-year readmissions and mortality rates in patients with and without AC.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Amyloidosis in Heart Failure (PREVAMIC)
Official Title Study of Prevalence of Amyloidosis in Heart Failure (PREVAMIC).
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.

Detailed Description

STUDY DESIGN AND PATIENT SELECTION

DESIGN

Multicenter, observational, cross-sectional, prospective, cohort study with a one-year follow-up. Approximately 450 patients will be gathered (according to the calculation of the sample size, 382 patients would be necessary), of both sexes (with stratification Male:Female 1:1), age ≥ 65 years, under the care of Internal Medicine Services, who meet the criteria of the 2016 Heart Failure Guide of the European Society of Cardiology for the diagnosis of Heart Failure, and that have LVH (Septum or Posterior Wall > 12 mm).

Patients will be duly informed of the study and their written informed consent will be requested prior to their enrollment in the study.

Once included in the study a series of clinical, analytical and echocardiographic parameters will be collected and measured.

  • It will be performed:

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

      • Proteinogram and serum immunoglobulins.
      • Free light chains 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 during 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.

POPULATION Inpatients or outpatients of Internal Medicine Services with diagnosis of Heart Failure from the participating centers, selected by the inclusion and exclusion criteria defined for our study, in appropriate number, according to the calculation of the sample size, to assess the main objective.

SELECTION OF HOSPITALS AND PATIENTS All eligible patients will be candidates to enter the study (that is, all those who meet the inclusion criteria and do not meet any exclusion criteria).

The study will involve all Spanish hospitals that voluntarily desire to participate and that have the necessary diagnostic methods to carry out the study. To participate in the study, no minimum hospital size (number of beds) has been set.

DATA COLLECTION AND WORK STRATEGY IN EACH HOSPITAL. The number of cases to be collected by each hospital will be calculated proportionally based on the total number of beds in each center. The number of patients that each center should include refers to the total number of patients.

Data collection will begin the same week of the year for all hospitals. All cases that meet inclusion criteria and none of exclusion and sign the consent will be collected consecutively, with gender stratification (50% men and 50% women of the number of patients assigned to the center) until at least the number of patients assigned to the center is completed . Optionally, patients may continue to be included, in that week or in subsequent weeks,as long as it is done consecutively and stratified by sex (without selecting the cases).

ETHICAL ASPECTS The patients included in this study will be treated according to standard medical care, since being a prevalence study that does not change the usual clinical practice. The study will be carried out in accordance with the Declaration of Helsinki and the Spanish Organic Law on the Protection of Personal Data and Guarantee of Digital Rights.

The study has been approved by the Clinical Research Ethics Committee (CEI) of the Virgen Macarena-Virgen del Rocío University Hospitals. In those cases that are necessary, the approval of the other local CEIs will also be requested.

The researchers of each participating center will explain to each patient all the aspects of the study and the patients will be given an information sheet giving details of it, making it clear that participation is voluntary and that they can leave the study at any time if they wish. If the patient wants to participate, both the investigator and the patient himself, or his legal representative in case of disability, must sign the informed consent. The patient will be given a copy of the consent.

DATABASE An online Database will be developed to record the data of the study patients.

STATISTIC ANALYSIS Continuous variables will be expressed with the value of the mean and standard deviation or as median and interquartile range, depending on the normality of their distribution. Categorical variables will be expressed in percentages or rates. A descriptive analysis of the data will be made, calculating the prevalence rates, and a comparative analysis in relation to different variables, such as gender, age and other factors that are of interest for the objective of the study.

The comparison will be made using the Chi-square test in the categorical variables and the Student's T test for normal quantitative variables. For non-normal quantitative variables, the non-parametric U-Mann Whitney test will be used. Regarding the follow-up data, the association of different variables with the re-entry and mortality data will be assessed using univariate and multivariate analysis. Survival curve analysis will also be performed using the Kaplan-Meier method using log-rank test. A p <0.05 will be considered statistical significance.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Heart Failure
Intervention
  • 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.
Study Groups/Cohorts 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.
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 22, 2019)
450
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Oscar Aramburu Bodas Aramburu Bodas oscarab2000@gmail.com
Contact: Oscar Aramburu Bodas 955 00 80 00 oscarab2000@gmail.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04066452
Other Study ID Numbers FIS-AMI-2019-01
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 Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators Not Provided
Investigators
Principal Investigator: Prado Salamanca Bautista Hospital Universitario Virgen Macarena
PRS Account Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Verification Date August 2019