Ignite Creation Date:
2025-12-18 @ 8:12 AM
Ignite Modification Date:
2025-12-23 @ 6:23 PM
Study NCT ID:
NCT07211724
Status:
None
Last Update Posted:
2025-10-08 00:00:00
First Post:
2025-09-23 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Methamphetamine Use Disorder Support in Heart Failure Pilot Study
Sponsor:
None
Organization:
Study Overview
Official Title:
Methamphetamine Use Disorder Support in Heart Failure (Meth HF) Pilot Study
Status:
None
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Meth-HF
Brief Summary:
Prospective, open-label, single-arm study to evaluate the feasibility and preliminary efficacy of a multidisciplinary HF clinic which integrates MUD management along with standard-of-care guideline directed HF management. The MUD treatment plan will be pragmatic, consisting of behavioral counseling, CM with or without pharmacotherapy (see below). Patients with HF and concomitant active meth use will be enrolled consecutively and managed in the clinic for 6 months. The pragmatic approach to MUD treatment will allow for individualization of therapy plans reflecting current MUD guidelines. The overarching objective of the current proposal is to demonstrate the feasibility and preliminary value of a HF clinic for meth users that integrates MUD treatment. The central hypothesis is that incorporation of simultaneous meth use abstinence incentives and aid with HF management in a singular clinic visit model will improve care delivery metrics associated with improved HF outcomes. The hypothesis aligns with HF guidelines that emphasize the essential role of incorporating comorbidity management into routine care of patients with HF.
Specific Aim 1 will define the rate of successful abstinence from meth with implementation of a multidisciplinary meth HF clinic utilizing contingency +/- pharmacologic management strategies alongside standard HF care in a prospective, open-label pragmatic study. Patients with HF and documented meth use will be consecutively enrolled for follow-up in the study clinic. Along with standard-of-care management of HF, patients will work with the addiction medicine pharmacist to receive an individualized MUD treatment plan for 6 months. Implementation of an effective MUD treatment plan will result in both improved abstinence from meth, as well as adherence to clinic visits and HF therapies over the 6 months of follow-up, establishing the feasibility and model for this multidisciplinary integrated clinic.
Specific Aim 2 will assess the clinical value of the meth HF clinic to improve HF care quality metrics. As a pilot study, patient adherence to HF GDMT and follow-up appointments will be descriptively quantified, along with achievement of GDMT target doses at 1, 3, and 6 months. Changes in patient quality of life from baseline will be ascertained utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Since MUD represents an established barrier to patient adherence with medical therapies, the integration of MUD with HF care will improve these HF care quality metrics associated with improved patient outcomes in HF. These data will demonstrate the preliminary value for this multidisciplinary integrated clinic.
Specific Aim 3 will enumerate the healthcare resources and costs required for implementation, and further attempt to estimate the range of cost savings associated with the meth HF clinic. To demonstrate feasibility and replicability, the costs associated with this care model will be estimated through prospective collection of care delivery data across all study patients, including personnel time and other direct costs of the MUD treatment. Cost savings will be estimated based on projected reductions in health resource use (e.g., reduced out- and inpatient encounters). The cost and savings components will be the foundation for designing both a payer-perspective budget impact analysis, and a societal-perspective full cost-effectiveness analysis for incorporation into a future randomized, controlled study of the clinical and economic impacts of the clinic.
The study will establish the feasibility and preliminary value of an innovative model of care delivery for very high-risk patients with HF and MUD that reduces barriers to optimizing the care and benefit. The broader impact will be established by demonstrating that increased meth abstinence improves adherence and GDMT optimization, underscoring the value of systems that provide a holistic patient-centric approach to HF management. Specifically, the achievement of many of the guideline-recommended HF clinical performance and quality measures can be enhanced by incorporating SUD treatment into the standard of care for HF.
Specific Aim 1 will define the rate of successful abstinence from meth with implementation of a multidisciplinary meth HF clinic utilizing contingency +/- pharmacologic management strategies alongside standard HF care in a prospective, open-label pragmatic study. Patients with HF and documented meth use will be consecutively enrolled for follow-up in the study clinic. Along with standard-of-care management of HF, patients will work with the addiction medicine pharmacist to receive an individualized MUD treatment plan for 6 months. Implementation of an effective MUD treatment plan will result in both improved abstinence from meth, as well as adherence to clinic visits and HF therapies over the 6 months of follow-up, establishing the feasibility and model for this multidisciplinary integrated clinic.
Specific Aim 2 will assess the clinical value of the meth HF clinic to improve HF care quality metrics. As a pilot study, patient adherence to HF GDMT and follow-up appointments will be descriptively quantified, along with achievement of GDMT target doses at 1, 3, and 6 months. Changes in patient quality of life from baseline will be ascertained utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Since MUD represents an established barrier to patient adherence with medical therapies, the integration of MUD with HF care will improve these HF care quality metrics associated with improved patient outcomes in HF. These data will demonstrate the preliminary value for this multidisciplinary integrated clinic.
Specific Aim 3 will enumerate the healthcare resources and costs required for implementation, and further attempt to estimate the range of cost savings associated with the meth HF clinic. To demonstrate feasibility and replicability, the costs associated with this care model will be estimated through prospective collection of care delivery data across all study patients, including personnel time and other direct costs of the MUD treatment. Cost savings will be estimated based on projected reductions in health resource use (e.g., reduced out- and inpatient encounters). The cost and savings components will be the foundation for designing both a payer-perspective budget impact analysis, and a societal-perspective full cost-effectiveness analysis for incorporation into a future randomized, controlled study of the clinical and economic impacts of the clinic.
The study will establish the feasibility and preliminary value of an innovative model of care delivery for very high-risk patients with HF and MUD that reduces barriers to optimizing the care and benefit. The broader impact will be established by demonstrating that increased meth abstinence improves adherence and GDMT optimization, underscoring the value of systems that provide a holistic patient-centric approach to HF management. Specifically, the achievement of many of the guideline-recommended HF clinical performance and quality measures can be enhanced by incorporating SUD treatment into the standard of care for HF.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: