Strategy, Efficacy and Safety of Medication Usage in Heart Failure Patients Who Were Intolerable to GDMT

Heart Failure With Reduced Ejection Fraction Clinical Trial

— SEMI  

Official title:

Medication Strategies in Heart Failure Patients Who Are Intolerable to Guideline-directed Medical Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05799638
• Other study ID #: SEMI-HF
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

SEMI trial is a single-center, observational, prospective cohort study. The study enrolled acute heart failure patients admitting to the hospital and intended to accept heart failure therapy. The current guideline recommend ACEI/ARB/ARNI, β blocker, SGLT2i and MRA as the cornerstone medication of HFrEF therapy, but a part patients were intolerable to GDMT because of hypotension, hyperkalemia or renal insufficency. Vericiguat is a new medication therapy choice for the patients with heart failure with reduced ejection fraction (HFrEF), it may has less influence on blood pressure, it is unkonwn about the efficacy and safety of vericiguat in patients who were intolerable to GDMT.

Description:

The study aim to provide evidence of medication strategy in heart failure patients, especially for patients who are intolerable for GDMT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Age = 18 years

2. Hospitalization and diagnosed with acute heart failure with typical symptoms and signs, such as dyspnea, shortness of breath and edema.

3. LVEF measured by echocardiogram = 45%.

4. Patients with elevated NT-proBNP (NT-proBNP = 125 pg/ml in sinus rate or = 350 pg/ml in atrial fibrillation)

Exclusion criteria:

1. LVEF measured by the UCG>45%

2. Used to diagnosed with heart failure with preserved ejection fraction.

3. Age =18 years.

4. Using or planned to be implanted with a ventricular assist device.

5. Severe and uncontrolled pulmonary disease, such as pneumoconiosis, newly developed pulmonary embolism, or chronic obstructive pulmonary disease requiring long-term oxygen therapy.

6. Severe and uncontrolled liver disease with Child-Pugh class C.

7. History of allergic or hypersensitivity to ACEIs, ARBs, ARNI, ß blockers, SGLT2is, MRAs and vericiguat.

8. Patients diagnosed with active myocarditis.

9. Probable alternative diagnoses could account for the patient's HF symptoms e.g., bronchial asthma, primary pulmonary hypertension.

10. Pregnant woman

11. Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate>150 bpm in AF patients.

12. Obvious stenosis of bilateral renal arteries.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• Guideline-Directed Medication Treatment (GDMT)
GDMT contains ACEIs/ARBs/ARNI, ß blockers, SGLT2is, MRAs. ACEI/ARB/ARNI and ß blocker will gradually be titrated up to the maximum tolerable dose

Locations

Country	Name	City	State
China	The first affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28. — View Citation

Armstrong PW, Roessig L, Patel MJ, Anstrom KJ, Butler J, Voors AA, Lam CSP, Ponikowski P, Temple T, Pieske B, Ezekowitz J, Hernandez AF, Koglin J, O'Connor CM. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator: The VICTORIA Trial. JACC Heart Fail. 2018 Feb;6(2):96-104. doi: 10.1016/j.jchf.2017.08.013. Epub 2017 Oct 11. — View Citation

Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1. Erratum In: Circulation. 2022 May 3;145(18):e1033. Circulation. 2022 Sep 27;146(13):e185. Circulation. 2023 Apr 4;147(14):e674. — View Citation

McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. Erratum In: Eur Heart J. 2021 Oct 14;: — View Citation

Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality or worsening heart failure in 180 days	Risk of all-cause death, readmission due to heart failure or accepting intravenous diuretic therapy in 180 days	180 days
Secondary	Change in symptoms and signs of heart failure	Change in symptoms and signs of heart failure measured by New York Heart Association (NYHA) class 1 to 4	180 days
Secondary	Change in N-terminal pro-B type natriuretic peptide	Change in NT-proBNP level from baseline to 180 days or endpoint	180 days
Secondary	Change in left ventricular ejection fraction (LVEF)	Change in LVEF measured by echocardiogram from baseline to 180 days or endpoint	180 days
Secondary	Change in left ventricular end-diastolic diameter (LVEDD)	Change in LVEDD measured by echocardiogram from baseline to 180 days or endpoint	180 days
Secondary	Change in left ventricular end-systolic diameter (LVESD)	Change in LVESD measured by echocardiogram from baseline to 180 days or endpoint	180 days
Secondary	Change in left ventricular fractional shortening (LVFS)	Change in LVFS measured by echocardiogram from baseline to 180 days or endpoint	180 days
Secondary	Change in blood pressure	Systolic and diastolic blood pressures were measured at admission, discharge, and up-titration to the maximum tolerated dosage	180 days
Secondary	Change in blood potassium	Blood potassium were measured in baseline and endpoint	180 days