HeartMed-HF Digital Therapeutics Improves Exercise Capacity in CHF Patients After AMI

NCT06478732 | Not Yet Recruiting

• 1 other identifier: 031
• Study Type: interventional
• Target: 710
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic heart failure (HF) is a severe manifestation and terminal stage of various cardiovascular diseases, with high incidence and mortality rates. Myocardial infarction (MI) is currently one of the most common and significant causes of HF globally. The occurrence of HF after MI significantly increases the mortality risk for patients. Actively controlling risk factors and strengthening outpatient management of HF patients post-MI are crucial for alleviating clinical symptoms and enhancing exercise capacity. Recently, digital health interventions (DHI) have shown promising potential in managing cardiovascular disease patients. However, the application in patients with HF post-MI has not been well-reported. Therefore, this study independently and innovatively designed the HeartMed-HF digital therapeutics to demonstrate its effectiveness and safety in patients with HF after MI.

Conditions

Heart Failure

Keywords

heart failure; acute myocardial infarction; digital therapeutics

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake (peak VO2）

  Using cardiopulmonary exercise testing to measure peak VO2

  1 year

Secondary Outcomes (8)

• 6-minute walking test

  1 year

• Echocardiographic indexes

  1 year

• Cardiopulmonary exercise testing

  1 year

• Patient Health Questionnaire-9 (PHQ-9)

  1 year

• Generalized anxiety disorder-7 (GAD-7)

  1 year

Study Arms (2)

the experimental group

EXPERIMENTAL

receive comprehensive heart failure management

Other: health services

the controlled group

NO INTERVENTION

receive the current outpatient follow-up management

Interventions

health services OTHER

Implement comprehensive heart failure management for patients in the experimental group using the HeartMed-HF digital therapy

the experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be of either sex with age ≥ 18 years and ≤ 75 years.
• Hospitalization due to AMI (onset to randomization ≤ 2 weeks), including STEMI and NSTEMI.
• Meeting the diagnostic criteria for chronic HF, including:
• (1) Symptoms and/or signs of heart failure; (2) LVEF (Simpson's method) \< 50%, and NT-proBNP ≥ 125pg/mL before enrollment. 4. Patients must be willing to comply with the study protocol and give the informed consent.

You may not qualify if:

• Contraindications to cardiopulmonary exercise testing (bicycle ergometer) or 6-minute walking test.
• Pregnancy, breastfeeding, or planning pregnacy within 1 year.
• Patients who have undergone mechanical circulatory support (including intra-aortic balloon pump, Impella, ECMO, etc.) or endotracheal intubation.
• History of viral cardiomytis or non-ischemic cardiomyopathy including dilated cardiomyopathy, hypertrophic cardiomyopathy, perinatal cardiomyopathy, etc.
• Moderate to severe valvular heart disease or a history of valve replacement.
• Severe liver dysfunction \[ALT ≥ 3 times the upper limit of normal range or renal dysfunction (eGFR\<60 mL /min/1.73m2)\].
• Malignant tumors or other diseases, with expected life expectancy \<1 year.
• Inability to use smartphones or communicate with the management team for any reason.
• Enrolled in other clinical trials.
• Any other clinical conditions unsuitable for this study by the investigator.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Related Publications (13)

• Wang H, Chai K, Du M, Wang S, Cai JP, Li Y, Zeng P, Zhu W, Zhan S, Yang J. Prevalence and Incidence of Heart Failure Among Urban Patients in China: A National Population-Based Analysis. Circ Heart Fail. 2021 Oct;14(10):e008406. doi: 10.1161/CIRCHEARTFAILURE.121.008406. Epub 2021 Aug 28.

  PMID: 34455858 BACKGROUND

• Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013.

  PMID: 35150240 BACKGROUND

• Velagaleti RS, Pencina MJ, Murabito JM, Wang TJ, Parikh NI, D'Agostino RB, Levy D, Kannel WB, Vasan RS. Long-term trends in the incidence of heart failure after myocardial infarction. Circulation. 2008 Nov 11;118(20):2057-62. doi: 10.1161/CIRCULATIONAHA.108.784215. Epub 2008 Oct 27.

  PMID: 18955667 BACKGROUND

• Cohen AB, Dorsey ER, Mathews SC, Bates DW, Safavi K. A digital health industry cohort across the health continuum. NPJ Digit Med. 2020 May 12;3:68. doi: 10.1038/s41746-020-0276-9. eCollection 2020.

  PMID: 32411829 BACKGROUND

• Chen C, Ding S, Wang J. Digital health for aging populations. Nat Med. 2023 Jul;29(7):1623-1630. doi: 10.1038/s41591-023-02391-8. Epub 2023 Jul 18.

  PMID: 37464029 BACKGROUND

• Vardas PE, Asselbergs FW, van Smeden M, Friedman P. The year in cardiovascular medicine 2021: digital health and innovation. Eur Heart J. 2022 Jan 31;43(4):271-279. doi: 10.1093/eurheartj/ehab874.

  PMID: 34974610 BACKGROUND

• Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

  PMID: 31722151 BACKGROUND

• Kerwagen F, Koehler K, Vettorazzi E, Stangl V, Koehler M, Halle M, Koehler F, Stork S. Remote patient management of heart failure across the ejection fraction spectrum: A pre-specified analysis of the TIM-HF2 trial. Eur J Heart Fail. 2023 Sep;25(9):1671-1681. doi: 10.1002/ejhf.2948. Epub 2023 Jul 31.

  PMID: 37368507 BACKGROUND

• Alshahrani NS, Hartley A, Howard J, Hajhosseiny R, Khawaja S, Seligman H, Akbari T, Alharbi BA, Bassett P, Al-Lamee R, Francis D, Kaura A, Kelshiker MA, Peters NS, Khamis R. Randomized Trial of Remote Assessment of Patients After an Acute Coronary Syndrome. J Am Coll Cardiol. 2024 Jun 11;83(23):2250-2259. doi: 10.1016/j.jacc.2024.03.398. Epub 2024 Apr 6.

  PMID: 38588928 BACKGROUND

• McManus RJ, Little P, Stuart B, Morton K, Raftery J, Kelly J, Bradbury K, Zhang J, Zhu S, Murray E, May CR, Mair FS, Michie S, Smith P, Band R, Ogburn E, Allen J, Rice C, Nuttall J, Williams B, Yardley L; HOME BP investigators. Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial. BMJ. 2021 Jan 19;372:m4858. doi: 10.1136/bmj.m4858.

  PMID: 33468518 BACKGROUND

• Victoria-Castro AM, Martin ML, Yamamoto Y, Melchinger H, Weinstein J, Nguyen A, Lee KA, Gerber B, Calderon F, Subair L, Lee V, Williams A, Shaw M, Arora T, Garcez A, Desai NR, Ahmad T, Wilson FP. Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. JACC Heart Fail. 2024 Feb;12(2):336-348. doi: 10.1016/j.jchf.2023.09.022. Epub 2023 Nov 8.

  PMID: 37943227 BACKGROUND

• Dorje T, Zhao G, Tso K, Wang J, Chen Y, Tsokey L, Tan BK, Scheer A, Jacques A, Li Z, Wang R, Chow CK, Ge J, Maiorana A. Smartphone and social media-based cardiac rehabilitation and secondary prevention in China (SMART-CR/SP): a parallel-group, single-blind, randomised controlled trial. Lancet Digit Health. 2019 Nov;1(7):e363-e374. doi: 10.1016/S2589-7500(19)30151-7. Epub 2019 Oct 10.

  PMID: 33323210 BACKGROUND

• Treskes RW, van Winden LAM, van Keulen N, van der Velde ET, Beeres SLMA, Atsma DE, Schalij MJ. Effect of Smartphone-Enabled Health Monitoring Devices vs Regular Follow-up on Blood Pressure Control Among Patients After Myocardial Infarction: A Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e202165. doi: 10.1001/jamanetworkopen.2020.2165.

  PMID: 32297946 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Health Services

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Central Study Contacts

Chunjian Li, PHD

CONTACT

13701465229; lijay@njmu.edu.cn

Tian Wu, MD

CONTACT

15651751103; wu_tian97@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 27, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share