Clinical trial NCT05799638: Strategy, Efficacy and Safety of Medication Usage in Heart Failure Patients Who Were Intolerable to GDMT
Official title: Medication Strategies in Heart Failure Patients Who Are Intolerable to Guideline-directed Medical Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: heart failure
myocardial fibrosis
vericiguat
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients enrolled in the study were recruited from a single center. The patients were admitted to hospital and diagnosed with acute heart failure.

Brief summary: SEMI trial is a single-center, real-world based 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.

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

Eligibility criteria: Inclusion Criteria:

1. Sent to the Department of Cardiovascular disease of The First Affiliated Hospital of Chongqing Medical University for inpatient treatment.
2. Diagnosed with acute heart failure or acute exacerbation of chronic heart failure
3. Patients with typical heart failure symptoms and signs such as dyspnea, fatigue after exercise, paroxysmal nocturnal dyspnea, lower limb edema, lung auscultation rale, etc.
4. Left ventricular ejection fraction measured by echocardiogram ≤ 45% and patients had elevated level of NT-proBNP (patients\<55 years, NT-proBNP\>450 pg/mL; patients≥55 years and \<75 years, NT-proBNP\>900 pg/mL; patients ≥ 75 years, NT-proBNP\>1800 pg/mL)
5. New York Heart Association functional class II to IV.

Exclusion Criteria:

1. Left ventricular ejection fraction measured by echocardiogram \> 45% or diagnosed with heart failure with preserved ejection fraction.
2. Age ≤ 18 years old.
3. Allergic to anti-heart failure medications including ACEI/ARB/ARNI, beta blockers, SGLT2i, oral diuretics and vericiguat.
4. Diagnosed as other diseases with symptoms similar to heart failure such as acute exacerbation of chronic obstructive pulmonary disease, etc.
5. Dignosed with acute coronary syndrome, including unstable angina, non ST-elevation myocardial infarction and ST-elevation myocardial infarction. Received percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to the trial start, or indication for PCI or CABG at the trial start.
6. Hepatic insufficiency classified as Child-Pugh B or C.
7. Diagnosed with restrictive cardiomyopathy.
8. Diagnosed with cardiac amyloidosis, Fabry disease or other rare cardiomyopathy.
9. Diagnosed with systematic lupus erythematosus or other autoimmune disease.
10. Diagnosed with or suspect diagnosed with active tumor.
11. Diagnosed with idiopathic pulmonary hypertension, receiving PDE-5 inhibitor or other sGC stimulators.
12. Pregnant woman.
13. Combined with severe infection at admission or combined with uncontrolled tuberculosis.
14. Diagnosed with severe and uncontrolled congenital heart disease.
15. Patients with rheumatic valvular disease who have indications for surgery but have not undergone surgical treatment.

Primary outcomes:
measure: Worsening heart failure events in 180 days
timeFrame: 180 days
Secondary outcomes:
measure: Change in N-terminal pro-B type natriuretic peptide
timeFrame: 180 days
measure: Change in left ventricular ejection fraction (LVEF)
timeFrame: 180 days
measure: Change in left ventricular end-diastolic diameter (LVEDD)
timeFrame: 180 days
measure: Change in left ventricular end-systolic diameter (LVESD)
timeFrame: 180 days
measure: Change in left ventricular fractional shortening (LVFS)
timeFrame: 180 days
measure: Change in blood pressure
timeFrame: 180 days
measure: Change in blood potassium
timeFrame: 180 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The first affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dongying Zhang, Ph.D
role: STUDY_CHAIR
References:
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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.
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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.