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

NCT05299879 | Unknown

• 1 other identifier: RH-SAINTS-A
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Advanced heart failure; Screening

Outcome Measures

Primary Outcomes (1)

• Proportion of patients screened who fulfill advanced HF criteria using a modified HFA-ESC definition

  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 Outcomes (16)

• Proportion of patients offered heart transplant listing < 3 months after primary outcome

  3 months after meeting modified HFA-ESC criteria for advanced HF

• Proportion of patients offered LVAD implantation < 3 months after primary outcome

  3 months after meeting modified HFA-ESC criteria for advanced HF

• Proportion of patients listed for heart transplantation < 3 months after primary outcome

  3 months after meeting modified HFA-ESC criteria for advanced HF

• Proportion of patients undergoing LVAD implantation < 3 months after primary outcome

  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

  Within 30 days from screening

Study Arms (1)

Symptomatic patients with HFrEF corresponding to NYHA II-III

Diagnostic Test: Cardiopulmonary exercise test, NT-proBNP, Echocardiography, 6 minute walk test, Right heart catheterization

Interventions

Cardiopulmonary exercise test, NT-proBNP, Echocardiography, 6 minute walk test, Right heart catheterization DIAGNOSTIC_TEST

Screening for advanced HF with modified criteria from the Heart Failure Association of the European Society of Cardiology

Symptomatic patients with HFrEF corresponding to NYHA II-III

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed in Danish HF clinics in the Copenhagen region.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Novo Nordisk A/S: collaborator

Study Sites (6)

Bispebjerg-Frederiksberg Hospital

Copenhagen, 2400, Denmark

NOT YET RECRUITING

Amager/Hvidovre Hospital

Copenhagen, 2650, Denmark

NOT YET RECRUITING

Herlev and Gentofte Hospital

Copenhagen, 2730, Denmark

NOT YET RECRUITING

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

RECRUITING

Nordsjællands Hospital Hillerød

Hillerød, 3400, Denmark

NOT YET RECRUITING

Zeeland University Hospital Roskilde

Roskilde, 4000, Denmark

NOT YET RECRUITING

Related Publications (1)

• Crespo-Leiro MG, Metra M, Lund LH, Milicic D, Costanzo MR, Filippatos G, Gustafsson F, Tsui S, Barge-Caballero E, De Jonge N, Frigerio M, Hamdan R, Hasin T, Hulsmann M, Nalbantgil S, Potena L, Bauersachs J, Gkouziouta A, Ruhparwar A, Ristic AD, Straburzynska-Migaj E, McDonagh T, Seferovic P, Ruschitzka F. Advanced heart failure: a position statement of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2018 Nov;20(11):1505-1535. doi: 10.1002/ejhf.1236. Epub 2018 Jul 17.

  PMID: 29806100 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Full blood

MeSH Terms

Interventions

Exercise Test; Echocardiography; Walk Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Officials

• Finn Gustafsson, MD, PhD, DMSci

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Finn Gustafsson, MD, PhD, DMSci

CONTACT

+45 35459743; finng@dadlnet.dk

Johan Larsson, MD

CONTACT

+45 50298907; johanlarsson923@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 29, 2022
• Study Start: October 24, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

DK (6)