Screening for Advanced Heart Failure IN Stable outPatientS - The SAINTS Study (SAINTS B)

NCT05284955 | Unknown Phase 4 FDA Device

• 1 other identifier: RH-SAINTS-B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

SAINTS B is a randomized, controlled, clinical trial. Patients identified with advanced heart failure in SAINTS A who are unwilling or unable to undergo heart transplantation or left ventricular assist device implantation will be invited to participate in this study. Included patients will be randomized in a 1:1 ratio to pharmacological HF treatment guided by an implanted wireless pulmonary artery hemodynamic monitor (CardioMEMS HF system) or usual care consisting of pharmacological HF treatment. Patients randomized into the CardioMEMS arm will be implanted within 30 (Cardiomems group only) days from randomization. After randomization, patients in both the CardioMEMS and the control arm will be seen at the outpatient clinic at Rigshospitalet after one and 6 months. At the final clinical follow-up visit at 6 months, participants will perform a 6 minute walk test (6MWT), cardiopulmonary exercise test (CPET), fill out a quality of life questionnaire (Kansas City Cardiomyopathy Questionnaire (KCCQ)) and blood samples will be drawn. Patients in the CardioMEMS arm will be managed according to previously published protocols for pulmonary artery pressure optimization (generally mean pulmonary pressure 10-25 mmHg) (Ref 1).

Conditions

Advanced Heart Failure; Heart Failure With Reduced Ejection Fraction

Keywords

Advanced heart failure; Pulmonary pressure; Hemodynamics; Remote monitoring; Randomized controlled clinical trial

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life from baseline to 6 months follow-up measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score

  The Kansas City Cardiomyopathy Questionnaire (KCCQ) score is a validated measure of quality of life in patients with HF. The range of the scale is 0-100, with higher values representing better quality of life.

  6 months from inclusion

Secondary Outcomes (14)

• Mean pulmonary artery pressure and diastolic pulmonary artery pressure

  3 months from inclusion

• Proportion reaching the preset pressure goal after 3 months

  3 months from inclusion

• Proportion reaching the preset pressure goal adjusted for baseline pulmonary artery pulsatility index

  3 months from inclusion

• Proportion of functioning devices

  6 months

• Proportion of patients improving > 5 points on KCCQ score

  6 months

Study Arms (2)

CardioMEMS HF System group

EXPERIMENTAL

Pharmacological heart failure treatment guided by an implanted wireless pulmonary artery hemodynamic monitor (CardioMEMS HF system)

Device: CardioMEMS HF System

Standard of care

ACTIVE COMPARATOR

Standard heart failure medical treatment

Drug: Standard heart failure medical therapy

Interventions

CardioMEMS HF System DEVICE

The CardioMEMS HF System is a wireless pulmonary artery pressure monitor. We will use measurements from the device to guide medical heart failure therapy.

CardioMEMS HF System group

Standard heart failure medical therapy DRUG

Standard heart failure medical therapy as recommended by guidelines.

Standard of care

Eligibility Criteria

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

You may qualify if:

• Included in SAINTS A and fulfilling criteria for advanced HF (i.e., meeting primary endpoint for SAINTS A), although with a lower NT-proBNP cut-off level at ≥ 1000 pg/ml, but not referred for HTx or LVAD due to contraindications or patient preference
• NYHA Functional class III
• Be willing and able to upload pulmonary artery pressure information and comply with the follow-up requirements

You may not qualify if:

• Systolic blood pressure \< 90 mmHg
• Chest circumference of \> 165 cm if BMI is ≥35 kg/m2
• Intolerance to all neurohormonal antagonists (i.e., intolerance to Angiotensin Converting Enzyme inhibitors (ACE-I), Angiotensin Receptor Blockers (ARBs), Angiotensin receptor II blocker - neprilysin inhibitor (ARNi), Mineralocorticoid Receptor Antagonists (MRA), hydralazine/isosorbide dinitrate, and betablockers)
• Fluid overload with a maximum (or dose equivalent) diuretic intervention
• Contraindications to 1-month dual antiplatelet therapy or anticoagulation therapy for post implantation
• Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS pulmonary artery sensor
• Implanted with mechanical right heart valve(s)
• Pregnant or planning to become pregnant in the next 12 months
• An active, ongoing infection
• History of current or recurrent (≥2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thromboses

Sponsors & Collaborators

• Finn Gustafsson: lead
• Novo Nordisk A/S: collaborator
• Abbott: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (4)

• Lindenfeld J, Abraham WT, Maisel A, Zile M, Smart F, Costanzo MR, Mehra MR, Ducharme A, Sears SF, Desai AS, Paul S, Sood P, Johnson N, Ginn G, Adamson PB. Hemodynamic-GUIDEd management of Heart Failure (GUIDE-HF). Am Heart J. 2019 Aug;214:18-27. doi: 10.1016/j.ahj.2019.04.014. Epub 2019 May 3. No abstract available.

  PMID: 31150790 BACKGROUND

• Aaronson KD, Stewart GC, Pagani FD, Stevenson LW, Palardy M, McNamara DM, Mancini DM, Grady K, Gorcsan J, Kormos R, Jeffries N, Taddei-Peters WC, Richards B, Khalatbari S, Spino C, Baldwin JT, Mann DL; REVIVAL Investigators. Registry Evaluation of Vital Information for VADs in Ambulatory Life (REVIVAL): Rationale, design, baseline characteristics, and inclusion criteria performance. J Heart Lung Transplant. 2020 Jan;39(1):7-15. doi: 10.1016/j.healun.2019.09.008. Epub 2019 Sep 14.

  PMID: 31679943 BACKGROUND

• Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.

  PMID: 33185990 BACKGROUND

• Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030.

  PMID: 28705314 BACKGROUND

Study Officials

• Finn Gustafsson, MD, professor, PhD, DMSci

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Finn Gustafsson, MD, professor, PhD, DMSci

CONTACT

+45 3545 9743; finng@dadlnet.dk

Johan E Larsson, MD

CONTACT

+45 3545 8096; johanlarsson@dadlnet.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: March 2, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)