Screening for Advanced Heart Failure IN Stable ouTpatientS - The SAINTS Study (SAINTS-A)

October 31, 2022 updated by: Finn Gustafsson, Rigshospitalet, Denmark

Screening for Advanced Heart Failure IN Stable ouTpatientS (The SAINTS Study) - Early Identification of Advanced Heart Failure

The purpose of the Screening for Advanced heart failure IN stable ouTpatientS (SAINTS) study is to determine the prevalence of advanced heart failure (HF) in symptomatic patients with HF and reduced left ventricular ejection fraction (HFrEF), corresponding to the New York Heart Association functional class II-III.

Recognition of advanced HF is a challenge for physicians and under referral for advanced management is a considerable problem. There are excellent treatment options for patients with advanced HF, i.e. heart transplantation or left ventricular assist device (LVAD) implantation, and outcomes with these therapies are considerably better if patients are treated before irreversible end-organ damage occurs. International consensus highlights the importance of timely recognition and referral of these patients to advanced HF centers.

The investigators aim to screen patients with symptomatic HFrEF who are followed in Danish HF clinics in the Copenhagen region with echocardiography, cardiopulmonary exercise test, 6 minute walk test, and NT-proBNP. The investigators hypothesize that 20% of patients with symptomatic heart failure followed in HF clinics in the Copenhagen Region will fulfill the modified criteria for advanced HF from the HFA-ESC (primary end-point in the study)(Reference 1). Patients who are identified with advanced HF will be offered right heart catheterization, guided by ultrasound and inserted through the internal jugular vein, determining pulmonary capillary wedge pressure, cardiac index, central venous pressure, mean pulmonary artery pressure, and central venous oxygen saturation. Patients not fulfilling criteria for advanced HF will be offered right heart catheterization consecutively until 50 patients have been examined (this group will be a comparator group to the patients with advanced HF).

Patients identified with advanced HF will be offered listing for HTx or LVAD if an indication without a contraindication is present. Patients who fulfill the primary endpoint of modified HFA-ESC criteria for advanced HF, and are ineligible for, or unwilling to undergo HTx or LVAD implantation will be invited to participate in the SAINTS B study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Number of patients and sample size More than 3000 patients are followed in the HF clinics on Zealand including the greater Copenhagen region. The investigators plan to include 400 patients in the primary outcome analysis (SAINTS A) and hypothesize that 20% will fulfill the modified criteria for advanced HF.

Statistical analysis Descriptive statistics will be reported as mean +/- standard deviation (SD) or median (interquartile range (IQR)) depending on distribution. Comparisons between groups at baseline will be performed by unpaired t-tests for normally distributed continuous variables, by the Mann-Whitney U test (Wilcoxon rank-sum) for non-normally distributed continuous variables and χ2 or Fisher's exact test for categorical variables.

The primary outcome will be analyzed as the proportion n (%) of included patients who fulfill the modified HFA-ESC criteria for advanced HF. As for secondary outcomes, the investigators will analyze the proportion n (%) of patients who within the first 3 months are; 1) offered heart transplant listing, 2) offered LVAD implantation, 3) listed for HTx and 4) undergoing LVAD implantation. Further, comparisons of invasive hemodynamics, CPET measures, 6MWT, QoL and NTproBNP levels between patients with and without advanced HF will be made using an unpaired t-test or the Mann-Whitney U test for non-normally distributed continuous variables.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Finn Gustafsson, MD, PhD, DMSci
  • Phone Number: +45 35459743
  • Email: finng@dadlnet.dk

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Not yet recruiting
        • Bispebjerg-Frederiksberg Hospital
        • Contact:
          • Olav Wendelbo Nielsen, MD, ph.d, dr.med.
      • Copenhagen, Denmark, 2650
        • Not yet recruiting
        • Amager/Hvidovre Hospital
        • Contact:
          • Morten Petersen, MD, ph.d
      • Copenhagen, Denmark, 2730
        • Not yet recruiting
        • Herlev and Gentofte Hospital
        • Contact:
          • Morten Schou, MD, ph.d
      • Glostrup, Denmark, 2600
        • Recruiting
        • Glostrup Hospital
        • Contact:
          • Anders Barasa, MD, ph.d
      • Hillerød, Denmark, 3400
        • Not yet recruiting
        • Nordsjællands Hospital Hillerød
        • Contact:
          • Nis Stride, MD, ph.d
      • Roskilde, Denmark, 4000
        • Not yet recruiting
        • Zeeland University Hospital Roskilde
        • Contact:
          • Nadia Dridi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients followed in Danish HF clinics in the Copenhagen region.

Description

Inclusion Criteria:

  1. History of Chronic heart failure > 3 months
  2. Stable (no hospitalization last 3 months) NYHA functional class II-III
  3. HFrEF patients (Left ventricular ejection fraction (LVEF) ≤ 30%)
  4. On or attempted betablocker and Renin-Angiotensin System (RAS) inhibitor treatment
  5. Informed consent

Exclusion Criteria:

  1. Body Mass Index (BMI) > 40 kg/m2
  2. Chronic renal replacement therapy or estimated Glomerular Filtration Rate (eGFR) < 15 ml/min/1.73m2
  3. Cardiac Resynchronization Therapy (CRT) implantation < 3 months ago or planned CRT
  4. Severe primary valvular disease
  5. On waiting list for heart transplantation or referred for evaluation
  6. Cancer or other severe non-cardiac disease with estimated life expectancy less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Symptomatic patients with HFrEF corresponding to NYHA II-III
Diagnostic test: Cardiopulmonary exercise test, NT-proBNP, Echocardiography, 6 minute walk test, Right heart catheterization
Screening for advanced HF with modified criteria from the Heart Failure Association of the European Society of Cardiology

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients screened who fulfill advanced HF criteria using a modified HFA-ESC definition
Time Frame: At time of screening

Modified HFA-ESC criteria for advanced HF defined as:

• LVEF ≤ 30% as estimated by echocardiography

AND

• Peak oxygen uptake (VO2peak) < 12 ml/kg/min (14 if on betablocker) with a Respiratory Exchange Ratio (RER) > 1.05 OR < 50% expected for age and gender OR 6 minute walk test (6MWT) distance < 300 meters

AND

• N-terminal pro B-type natriuretic peptide (NTproBNP) > 2000 pg / ml
At time of screening

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients offered heart transplant listing < 3 months after primary outcome
Time Frame: 3 months after meeting modified HFA-ESC criteria for advanced HF
3 months after meeting modified HFA-ESC criteria for advanced HF
Proportion of patients offered LVAD implantation < 3 months after primary outcome
Time Frame: 3 months after meeting modified HFA-ESC criteria for advanced HF
3 months after meeting modified HFA-ESC criteria for advanced HF
Proportion of patients listed for heart transplantation < 3 months after primary outcome
Time Frame: 3 months after meeting modified HFA-ESC criteria for advanced HF
3 months after meeting modified HFA-ESC criteria for advanced HF
Proportion of patients undergoing LVAD implantation < 3 months after primary outcome
Time Frame: 3 months after meeting modified HFA-ESC criteria for advanced HF
3 months after meeting modified HFA-ESC criteria for advanced HF
Pulmonary capillary wedge pressure (PCWP) in mmHg compared between patients with, and without advanced HF
Time Frame: Within 30 days from screening
Measured during right heart catheterization
Within 30 days from screening
Cardiac index (CI) in l/min/m2 compared between patients with, and without advanced HF
Time Frame: Within 30 days from screening
Measured during right heart catheterization
Within 30 days from screening
Central venous pressure (CVP) in mmHg compared between patients with, and without advanced HF
Time Frame: Within 30 days from screening
Measured during right heart catheterization
Within 30 days from screening
Mean pulmonary artery pressure (mPAP) in mmHg compared between patients with, and without advanced HF
Time Frame: Within 30 days from screening
Measured during right heart catheterization
Within 30 days from screening
Central venous oxygen saturation in % compared between patients with, and without advanced HF
Time Frame: Within 30 days from screening
Measured during right heart catheterization
Within 30 days from screening
Peak oxygen uptake (VO2peak) in ml/kg/min compared between patients with, and without advanced HF
Time Frame: At time of screening
Measured during cardiopulmonary exercise test
At time of screening
Peak respiratory exhange ratio compared between patients with, and without advanced HF
Time Frame: At time of screening
The ratio between metabolic production of CO2 and the uptake of O2 measured during cardiopulmonary exercise test
At time of screening
Minute ventilation-to-carbon dioxide output slope (VE/VCO2) compared between patients with, and without advanced HF
Time Frame: At time of screening
The ratio between metabolic production of CO2 and the uptake of O2 measured during cardiopulmonary exercise test
At time of screening
Peak Borg scale score compared between patients with, and without advanced HF
Time Frame: At time of screening
The Borg scale score is a rating of perceived exertion on a scale from 6-20, with 6 representing at rest, and 20 the most strenuous exercise imaginable. Measured during cardiopulmonary exercise test
At time of screening
6 minute walk test compared between patients with, and without advanced HF
Time Frame: At screening
At screening
Quality of Life (Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: At screening
At screening
NT-proBNP compared between patients with, and without advanced HF
Time Frame: At screening
At screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RH-SAINTS-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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